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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03072238
Registration number
NCT03072238
Ethics application status
Date submitted
2/03/2017
Date registered
7/03/2017
Date last updated
7/06/2024
Titles & IDs
Public title
Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer
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Scientific title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer
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Secondary ID [1]
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2016-004429-17
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Secondary ID [2]
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CO39303
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Universal Trial Number (UTN)
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Trial acronym
IPATential150
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ipatasertib
Treatment: Drugs - Abiraterone
Treatment: Drugs - Placebo
Treatment: Drugs - Prednisone/Prednisolone
Active Comparator: Placebo + Abiraterone - Participants received Placebo plus Abiraterone (along with Prednisone/Prednisolone), administered orally in 28-day cycles.
Experimental: Ipatasertib + Abiraterone - Participants received Ipatasertib plus Abiraterone (along with Prednisone/Prednisolone), administered orally in 28-day cycles.
Treatment: Drugs: Ipatasertib
Oral tablets, 400 mg, given once daily (QD) beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity.
Treatment: Drugs: Abiraterone
Oral tablets of abiraterone, 1000 mg QD, taken on an empty stomach and swallowed whole with water.
Treatment: Drugs: Placebo
Oral tablets (matched to ipatasertib appearance), given QD beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity.
Treatment: Drugs: Prednisone/Prednisolone
Oral tablets of 5 mg, taken twice daily (BID) until disease progression or intolerable toxicity.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Investigator-Assessed Radiographic Progression-Free Survival (rPFS) Per PCWG3 Criteria (PTEN Loss Population)
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Assessment method [1]
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Radiographic progression-free survival is defined as time from date of randomization to the first occurrence of documented disease progression, as assessed by the investigator with use of the Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first. Disease progression for soft tissue is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the sum of diameters of target lesions; progression of non target lesions; the appearance of one or more new lesions. Disease progression for bone lesions is defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later. rPFS will be analyzed in participants with phosphatase and tensin homolog (PTEN) - loss tumors (using the Ventana PTEN immunohistochemistry (IHC) assay).
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Timepoint [1]
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Up to approximately 31 months
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Primary outcome [2]
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Investigator-Assessed Radiographic Progression-Free Survival (rPFS) Per PCWG3 Criteria (Intent-To-Treat (ITT) Population)
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Assessment method [2]
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Radiographic progression-free survival is defined as time from date of randomization to the first occurrence of documented disease progression, as assessed by the investigator with use of the Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first. Disease progression for soft tissue is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the sum of diameters of target lesions; progression of non target lesions; the appearance of one or more new lesions. Disease progression for bone lesions is defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later. rPFS will be analyzed in the Intent-to-Treat (ITT) population.
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Timepoint [2]
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Up to approximately 31 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Overall Survival (OS) is defined as the time from randomization to death due to any cause. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
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Timepoint [1]
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Up to approximately 7 years
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Secondary outcome [2]
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Time to Pain Progression
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Assessment method [2]
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Time to pain progression was defined as the time from randomization to the first occurrence of confirmed clinically meaningful cancer-related pain progression event. Cancer-related pain progression refers to pain onset for participants who are asymptomatic at baseline or pain worsening for those who are mildly symptomatic at baseline. Pain severity will be graded on a 10-point scale, with 0=no pain and 10=severe pain. Pain severity progression is defined as a = 2-point absolute increase from baseline. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
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Timepoint [2]
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Up to approximately 7 years
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Secondary outcome [3]
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Time to Initiation of Cytotoxic Chemotherapy
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Assessment method [3]
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Time to initiation of cytotoxic chemotherapy is defined as the time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy (use of antineoplastic agents: docetaxel, cabazitaxel, mitoxantrone, estramustine, cisplatin, carboplatin, cyclophosphamide, doxorubicin, mitomycin, irinotecan, 5-fluorouracil, gemcitabine, or etoposide) for prostate cancer. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
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Timepoint [3]
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Up to approximately 7 years
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Secondary outcome [4]
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Time to Function Deterioration
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Assessment method [4]
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Time to function deterioration was defined as the time from the date of randomisation to the date of 10-point or more decrease on either the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) PF (Physical Functioning) or RF (Role Functioning) scale scores (range, 0-100) held for two consecutive assessments, or a 10 point or more score decrease followed by death (any cause) within 28 days, whichever occurs first. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
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Timepoint [4]
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Up to approximately 7 years
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Secondary outcome [5]
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Time to Prostate-Specific Antigen (PSA) Progression
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Assessment method [5]
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Time to PSA progression is defined as the time from the date of randomization to the first occurrence of PSA progression, per the PCWG3 criteria. PSA progression is defined as a PSA increase that is = 25% and = 2 ng/mL above the baseline or the nadir, which is confirmed by a second value = 3 weeks later. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
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Timepoint [5]
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Up to approximately 7 years
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Secondary outcome [6]
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Time to First Opioid Use
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Assessment method [6]
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Time to first opioid use is defined as the documentation of the first opioid prescription for cancer-related pain followed by the participant's record of opioid intake or availability of an Analgesic Quantification Algorithm (AQA) daily score. Participants reporting use of opioid for cancer-related pain at baseline will be excluded from the analysis. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
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Timepoint [6]
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Up to approximately 7 years
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Secondary outcome [7]
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Time to Symptomatic Skeletal Event (SSE)
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Assessment method [7]
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Time to SSE is defined as the time interval from the date of randomization to the date of an SSE. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
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Timepoint [7]
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Up to approximately 7 years
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Secondary outcome [8]
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Objective Response Rate (ORR)
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Assessment method [8]
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An objective response is defined as a complete response (CR) or partial response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator using RECIST v1.1 and PCWG3 criteria, in participants with measurable disease at baseline. Participants without a post-baseline tumor assessment will be considered non-responders. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
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Timepoint [8]
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Up to approximately 7 years
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Secondary outcome [9]
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PSA Response Rate
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Assessment method [9]
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PSA response rate is defined as the percentage of participants achieving a PSA decline =50% from baseline. Participants without a post-baseline PSA assessment will be considered non-responders. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
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Timepoint [9]
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Up to approximately 7 years
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Secondary outcome [10]
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Investigator-Assessed rPFS Per PCWG3 Criteria in Participants With PTEN-Loss Tumors by Next-Generation Sequencing (NGS)
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Assessment method [10]
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Investigator-assessed rPFS is defined as time from date of randomization to the first occurrence of documented disease progression, as assessed by the investigator with use of the Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first and will be analyzed in participants with PTEN-loss tumors by NGS. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
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Timepoint [10]
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Up to approximately 7 years
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Secondary outcome [11]
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Duration of Response (DOR)
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Assessment method [11]
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Duration of Response (DOR) is defined as the time from first occurrence of a documented confirmed objective response until the time of documented disease progression as determined by the investigator using RECIST v1.1 and PCWG3 criteria, or death from any cause, whichever occurs first. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
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Timepoint [11]
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Up to approximately 7 years
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Secondary outcome [12]
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Percentage of Participants With Adverse Events (AEs)
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Assessment method [12]
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An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
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Timepoint [12]
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Baseline up until 28 days after the last dose of study drug or initiation of subsequent lines of anti-cancer therapy, whichever occurs first (up to a maximum of 7 years).
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Secondary outcome [13]
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Plasma Concentrations of Ipatasertib at Specified Timepoints
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Assessment method [13]
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Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants.
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Timepoint [13]
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1-3 hours post-dose (Cycle 1, Day 1; Cycle 1 Day 15 and Cycle 3 Day 1) and pre-dose at steady state (Cycle 1 Day 15, Cycle 3 Day 1, Cycle 6 Day 1) (each cycle length= 28 days)
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Secondary outcome [14]
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Plasma Concentrations of Abiraterone at Specified Timepoints
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Assessment method [14]
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Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants.
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Timepoint [14]
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Pre-dose at steady state in Cycle 1, Day 15 and Cycle 3 Day 1 (each cycle length= 28 days)
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Eligibility
Key inclusion criteria
- Eastern Collaborative Oncology Group (ECOG) performance status of 0 or 1 at screening
- Adequate hematologic and organ function within 28 days before the first study
treatment
- Ability to comply with the study protocol, in the investigator's judgment
- Willingness and ability of participants to use the electronic device to report
selected study outcomes; Caregivers and site staff can assist with patient diary input
but patient must be able to independently comprehend and answer the questionnaires
- Life expectancy of at least 6 months
- Agreement to remain abstinent (refrain from heterosexual intercourse) or use
contraceptive measures, and agreement to refrain from donating sperm
- For enrollment into the China extension cohort, residence in the People's Republic of
China
Disease-specific
- Histologically confirmed prostate adenocarcinoma without neuroendocrine
differentiation or small-cell features
- Consent to provide a formalin-fixed paraffin-embedded (FFPE) tissue block (preferred)
or a minimum of 15 (20 preferred) freshly cut unstained tumor slides from the most
recently collected, available tumor tissue accompanied by an associated pathology
report (with tumor content information, Gleason score, and disease staging) for PTEN
IHC and NGS testing and for other protocol-mandated secondary and exploratory
assessments. If only 12-14 slides are available, the patient may still be eligible for
the study, after discussion with and approval by the Medical Monitor. Cytologic or
fine-needle aspiration samples are not acceptable. Tumor tissue from bone metastases
is not acceptable
- A valid PTEN IHC result (testingcentral laboratory tested with results directly sent
to IxRS) (e.g., participants with an "invalid" or "failed" PTEN IHC result are not
permitted to enroll)
- Metastatic disease documented prior to randomization by clear evidence of bone lesions
on bone scan and/or measurable soft tissue disease by computed tomography (CT) and/or
magnetic resonance imaging (MRI) (at least one target lesion) according to RECIST v1.1
- Asymptomatic or mildly symptomatic form of prostate cancer
- Progressive disease before initiating study treatment
- Ongoing androgen deprivation with gonadotropin-releasing hormone (GnRH) analog or
bilateral orchiectomy, with serum testosterone <= 50 ng/dL (<= 1.7 nmol/L) within 28
days before randomization
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Inability or unwillingness to swallow whole pills
- History of malabsorption syndrome or other condition that would interfere with enteral
absorption
- Clinically significant history of liver disease consistent with Child-Pugh Class B or
C, including cirrhosis, current alcohol abuse, or current known active infection with
hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Need of more than 10 mg/day of prednisone or an equivalent dose of other
anti-inflammatory corticosteroids as a current systemic corticosteroid therapy to
treat a chronic disease (e.g., rheumatic disorder)
- Active infection requiring intravenous (IV) antibiotics within 14 days before Day 1,
Cycle 1
- Immunocompromised status because of current known active infection with HIV or because
of the use of immunosuppressive therapies for other conditions
- Major surgical procedure or significant traumatic injury within 28 days prior to Day
1, Cycle 1, or anticipation of the need for major surgery during study treatment
- History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such
as structural heart disease (e.g., severe left ventricular systolic dysfunction, left
ventricular hypertrophy), untreated coronary heart disease (symptomatic or with
ischemia demonstrated by diagnostic testing), myocardial infarction or atrial
thrombotic events within the past 6 months, severe unstable angina, New York Heart
Association Class III and IV heart disease or depressed left ventricular ejection
fraction (LVEF; previously documented LVEF < 50% without documentation of recovery),
clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia,
hypocalcemia), or family history of sudden unexplained death or long QT syndrome
- History of another malignancy within 5 years prior to randomization, except for either
adequately treated non-melanomatous carcinoma of the skin, adequately treated melanoma
in situ, adequately treated non-muscle-invasive urothelial carcinoma of the bladder
(Tis, Ta, and low grade T1 tumors), or other malignancies where the patient has
undergone potentially curative therapy with no evidence of disease and are deemed by
the treating physician to have a recurrence rate of <5% at 5 years
- Any other diseases, cardiovascular, pulmonary, or metabolic dysfunction, physical
examination finding, or clinical laboratory finding giving reasonable suspicion of a
disease or condition that contraindicates the use of an investigational drug or that
may affect the interpretation of the results or renders the participants at high risk
from treatment complications.
Disease-Specific
- Pathologic findings consistent with small-cell or neuroendocrine carcinoma of the
prostate
- Any therapy including chemotherapy (e.g., docetaxel) or biological therapy (e.g.,
vaccine, immunotherapy) for the treatment of castration-resistant prostate cancer.
Previous treatment with flutamide, steroidal anti-androgens, androgens, estrogens,
bicalutamide, nilutamide, or 5-a reductase inhibitor is permitted.
- Use of opioid medications for cancer-related pain, including codeine and
dextropropoxyphene, currently or any time within 4 weeks of Day 1, Cycle 1
- Prior treatment with abiraterone or other known potent CYP17 inhibitors (e.g.,
ketoconazole, orteronel) or investigational agents that block androgen synthesis.
Previous treatment with itraconazole and fluconazole is permitted.
- Prior treatment with enzalutamide or other potent androgen-receptor blockers, approved
or experimental (e.g., ARN-509, ODM-201, or galeterone)
- Prior treatment with flutamide (Eulexin®), steroidal anti-androgens (e.g., cyproterone
acetate, chlormadinone acetate), androgens, or estrogens treatment within 4 weeks of
Cycle 1, Day 1
- Prior treatment with bicalutamide (Casodex®) or nilutamide (Nilandron®) within 6 weeks
of Cycle 1, Day 1
- Prior treatment with 5-alpha reductase inhibitors within 4 weeks of Cycle 1, Day 1
- Prior treatment with systemic radiopharmaceuticals (e.g., radium-223 and
strontium-89). Radiopharmaceuticals for the purpose of imaging are permitted. Focal
palliative radiation to treat cancer-related pain is permitted provided that the last
treatment with radiation is at least 14 days prior to Cycle 1, Day 1.
- Prior treatment with approved or experimental therapeutic agents with known inhibition
of the PI3K pathway, including PI3K inhibitors, AKT inhibitors, and mTOR inhibitors
- Administration of an investigational therapeutic agent within 28 days of Cycle 1, Day
1
- Known untreated or active central nervous system (CNS) metastases (progressing or
requiring anticonvulsant medications or corticosteroids for symptomatic control); a CT
or MRI scan of the brain will be performed at screening if required by the local
health authority
- Any chronic therapy or use of food supplements that are strong CYP3A4/5 inducers or
inhibitors or sensitive substrates of CYP3A or CYP2D6 with a narrow therapeutic window
Abiraterone-Specific
- Uncontrolled hypertension (systolic blood pressure = 160 mmHg or diastolic blood
pressure = 95 mmHg)
- History of pituitary or adrenal dysfunction
- Any ongoing cardiac arrhythmias (including atrial fibrillation) that require medical
therapy
Ipatasertib-Specific
- Type 1 or Type 2 diabetes mellitus requiring insulin at study entry
- History of inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis),
active bowel inflammation (e.g., diverticulitis)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/06/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/04/2024
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Sample size
Target
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Accrual to date
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Final
1101
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Macquarie University Hospital - Macquarie Park
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Recruitment hospital [2]
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Adelaide Cancer Centre - Kurralta Park
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Recruitment hospital [3]
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Monash Medical Centre; Oncology - Clayton
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Recruitment hospital [4]
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Peter Maccallum Cancer Centre - Melbourne
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Recruitment hospital [5]
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Eastern Health; GU - Oncology - Melbourne
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Recruitment postcode(s) [1]
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2109 - Macquarie Park
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Recruitment postcode(s) [2]
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5037 - Kurralta Park
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment postcode(s) [5]
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3128 - Melbourne
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Recruitment outside Australia
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Maryland
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Massachusetts
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Utah
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Austria
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Graz
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Austria
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Linz
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Austria
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Salzburg
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Belgium
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Gent
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Kortrijk
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Liège
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Brazil
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RN
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Brazil
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RS
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Brazil
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Ontario
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Quebec
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China
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Beijing Shi
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China
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Nanjing City
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China
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Shanghai City
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China
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Shanghai
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China
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Xi'an
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Costa Rica
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San José
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Denmark
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Aarhus N
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0
0
Denmark
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0
0
Odense C
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France
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Angers
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France
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Caen
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France
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Clermont Ferrand
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France
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La Roche Sur Yon
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France
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Lille
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France
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Montpellier
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France
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Nice
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France
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Nimes
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France
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Paris
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France
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Poitiers
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France
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Saint-Mande
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France
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Suresnes
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France
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Villejuif
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Greece
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Athens
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Greece
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Patras
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Miskolc
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Country [63]
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Ireland
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Cork
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Country [64]
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Ireland
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Dublin
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Israel
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Haifa
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Israel
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Kfar-Saba
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Country [67]
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Israel
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Petach Tikva
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Country [68]
0
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Israel
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Ramat Gan
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Lazio
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0
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Italy
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Lombardia
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Italy
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Toscana
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Italy
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Trentino-Alto Adige
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Japan
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Aichi
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Japan
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Aomori
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Japan
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Chiba
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Japan
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Gunma
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Japan
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Hokkaido
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Country [80]
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Japan
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Ishikawa
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Japan
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Kanagawa
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Japan
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Kochi
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Japan
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Kumamoto
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Japan
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Kyoto
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Country [85]
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Yamaguchi
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Mexico
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Mexico CITY (federal District)
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Mexico
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Sinaloa
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Mexico
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Mexico
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Durango
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Norway
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Grålum
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Norway
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Lørenskog
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Poland
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?ód?
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Poland
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Opole
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Poland
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Warszawa
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Poland
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Wroc?aw
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Country [105]
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Russian Federation
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Altaj
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Russian Federation
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Moskovskaja Oblast
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Russian Federation
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Niznij Novgorod
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Spain
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Barcelona
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Country [109]
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Spain
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Cordoba
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Country [110]
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Spain
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Islas Baleares
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Country [111]
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Spain
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Navarra
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Chiangmai
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United Kingdom
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Blackburn
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United Kingdom
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Cambridge
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United Kingdom
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Leicester
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United Kingdom
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Manchester
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United Kingdom
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Northwood
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United Kingdom
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Sutton
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of
ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus
abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant
prostate cancer (mCRPC).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03072238
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Public notes
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Contacts
Principal investigator
Name
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0
Clinical Trials
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03072238
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