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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03072238




Registration number
NCT03072238
Ethics application status
Date submitted
2/03/2017
Date registered
7/03/2017

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
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
Secondary ID [1] 0 0
2016-004429-17
Secondary ID [2] 0 0
CO39303
Universal Trial Number (UTN)
Trial acronym
IPATential150
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigator-Assessed Radiographic Progression-Free Survival (rPFS) Per PCWG3 Criteria (PTEN Loss Population)
Timepoint [1] 0 0
Up to approximately 31 months
Primary outcome [2] 0 0
Investigator-Assessed Radiographic Progression-Free Survival (rPFS) Per PCWG3 Criteria (Intent-To-Treat (ITT) Population)
Timepoint [2] 0 0
Up to approximately 31 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 7 years
Secondary outcome [2] 0 0
Time to Pain Progression
Timepoint [2] 0 0
Up to approximately 7 years
Secondary outcome [3] 0 0
Time to Initiation of Cytotoxic Chemotherapy
Timepoint [3] 0 0
Up to approximately 7 years
Secondary outcome [4] 0 0
Time to Function Deterioration
Timepoint [4] 0 0
Up to approximately 7 years
Secondary outcome [5] 0 0
Time to Prostate-Specific Antigen (PSA) Progression
Timepoint [5] 0 0
Up to approximately 7 years
Secondary outcome [6] 0 0
Time to First Opioid Use
Timepoint [6] 0 0
Up to approximately 7 years
Secondary outcome [7] 0 0
Time to Symptomatic Skeletal Event (SSE)
Timepoint [7] 0 0
Up to approximately 7 years
Secondary outcome [8] 0 0
Objective Response Rate (ORR)
Timepoint [8] 0 0
Up to approximately 7 years
Secondary outcome [9] 0 0
PSA Response Rate
Timepoint [9] 0 0
Up to approximately 7 years
Secondary outcome [10] 0 0
Investigator-Assessed rPFS Per PCWG3 Criteria in Participants With PTEN-Loss Tumors by Next-Generation Sequencing (NGS)
Timepoint [10] 0 0
Up to approximately 7 years
Secondary outcome [11] 0 0
Duration of Response (DOR)
Timepoint [11] 0 0
Up to approximately 7 years
Secondary outcome [12] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [12] 0 0
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).
Secondary outcome [13] 0 0
Plasma Concentrations of Ipatasertib at Specified Timepoints
Timepoint [13] 0 0
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)
Secondary outcome [14] 0 0
Plasma Concentrations of Abiraterone at Specified Timepoints
Timepoint [14] 0 0
Pre-dose at steady state in Cycle 1, Day 15 and Cycle 3 Day 1 (each cycle length= 28 days)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/04/2024
Sample size
Target
Accrual to date
Final
1101
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [3] 0 0
Monash Medical Centre; Oncology - Clayton
Recruitment hospital [4] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment hospital [5] 0 0
Eastern Health; GU - Oncology - Melbourne
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
3128 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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Colorado
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Connecticut
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District of Columbia
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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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Michigan
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Missouri
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Nebraska
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Nevada
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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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Salzburg
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Gent
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Kortrijk
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Liège
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MG
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Aarhus N
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Porto
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Altaj
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Moskovskaja Oblast
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Niznij Novgorod
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Barcelona
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Cordoba
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Navarra
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Malaga
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Sevilla
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Taiwan
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Kaohsiung
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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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Sutton
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United Kingdom
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03072238