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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/NCT01578655
Registration number
NCT01578655
Ethics application status
Date submitted
9/04/2012
Date registered
17/04/2012
Date last updated
12/10/2016
Titles & IDs
Public title
Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer
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Scientific title
A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination With Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men With Metastatic Castrate Resistant Prostate Cancer (AFFINITY)
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Secondary ID [1]
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OGX-011-12
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Universal Trial Number (UTN)
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Trial acronym
AFFINITY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
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 - cabazitaxel
Treatment: Drugs - prednisone
Treatment: Drugs - custirsen sodium
Experimental: Cabazitaxel plus Custirsen - cabazitaxel, prednisone, and custirsen sodium
Active Comparator: Cabazitaxel - cabazitaxel and prednisone
Treatment: Drugs: cabazitaxel
Cabazitaxel (25mg/m² IV) is administered on day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles
Treatment: Drugs: prednisone
Prednisone (10 mg PO) is administered daily until disease progression, unacceptable toxicity, or completion of 10 cycles
Treatment: Drugs: custirsen sodium
Custirsen is administered as 3 loading doses (640 mg IV each) within 9 days, followed by weekly custirsen (640 mg IV) during each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles
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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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Survival in the intent-to-treat population
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Assessment method [1]
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To determine whether the survival for patients randomized to the investigational arm (cabazitaxel/prednisone plus custirsen) is consistent with longer survival as compared to patients randomized to the control arm (cabazitaxel/prednisone).
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Timepoint [1]
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3.4 years
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Primary outcome [2]
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Survival in the poor-prognosis patient population
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Assessment method [2]
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To determine whether the survival for patients randomized to the investigational arm (cabazitaxel/prednisone plus custirsen) and identified as having poor prognosis is consistent with longer survival as compared to patients randomized to the control arm (cabazitaxel/prednisone) and identified as having poor prognosis.
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Timepoint [2]
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2.7 years
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Secondary outcome [1]
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Progression-free survival at Day 140
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Assessment method [1]
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To compare the arms with respect to the proportion of patients having a milestone Day 140 status of Alive Without Event (within the window of Day 125-155 post-randomization). An event is defined as disease progression or death on or before Day 140.
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Timepoint [1]
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From randomization to Day 125 to Day 155
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Eligibility
Key inclusion criteria
- Histological or cytological diagnosis of adenocarcinoma of the prostate
- Metastatic disease on chest, abdominal, or pelvic CT scan and/or bone scan
- Previous first-line treatment for CRPC with a docetaxel-containing regimen
- Current progressive disease
- Increasing serum PSA level (for patients who progress based only on increasing serum
PSA level, a minimum starting value of 5.0 ng/mL is required)
- Baseline laboratory values as defined
- Willing to continue primary androgen suppression with gonadotropin-releasing hormone
(GnRH) analogues (unless treated with bilateral orchiectomy)
- Karnofsky score =70%
- At least 21 days have passed since completing radiotherapy
- At least 21 days have passed since receiving any investigational agent at the time of
randomization
- At least 21 days have passed since major surgery
- Recovered from any docetaxel therapy-related neuropathy to =grade 1 at the time of
randomization
- Recovered from all therapy related toxicity to =grade 2 (except alopecia, anemia, and
any signs or symptoms of androgen deprivation therapy) at the time of randomization
- Able to tolerate a starting dose of 25 mg/m² cabazitaxel
- Willing to not add, delete, or change current bisphosphonate or denosumab usage
- Able to tolerate oral prednisone at 10 mg per day
- Competent to provide written informed consent
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Minimum age
No limit
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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
- Received any other cytotoxic chemotherapy beyond the first-line docetaxel-containing
regimen as treatment for prostate cancer
- Received prior radioisotope with strontium 89 or samarium 153
- Received any cycling, intermittent, or continuous hormonal treatment within 21 days
prior to randomization with the exception of the continuous GnRH analogues (prior
treatment with abiraterone or MDV3100 is allowed as long as 21 days have passed since
last dose)
- Participated in a prior Phase 3 clinical study evaluating custirsen regardless of
study arm assignment
- Requiring ongoing treatment during the study with medications known to be either
strong CYP3A inhibitors or strong CYP3A inducers
- History of or current documented brain metastasis or carcinomatous meningitis, treated
or untreated
- Current symptomatic cord compression requiring surgery or radiation therapy
- Active second malignancy (except non melanomatous skin or superficial bladder cancer)
defined in general as requiring anticancer therapy or at high risk of recurrence
during the study
- Uncontrolled medical condition or significant concurrent illness that in the opinion
of the Investigator would preclude protocol therapy
- Known severe hypersensitivity to taxanes or polysorbate 80-containing drugs
- Planned concomitant participation in another clinical trial of an experimental agent,
vaccine, or device
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
1/08/2012
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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
1/07/2016
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Sample size
Target
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Accrual to date
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Final
630
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC
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Recruitment hospital [1]
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The Canberra Hospital - Garran
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Royal Prince Alfred Hospital - Camperdown
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St George Public Hospital - Kogarah
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Royal North Shore Hospital - Saint Leonards
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Westmead Hospital - Westmead
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Haematology and Oncology Clinics of Australia - Brisbane
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The Queen Elizabeth Hospital - Woodville South
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Royal Hobart Hospital - Hobart
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Box Hill Hospital - Box Hill
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Austin Health - Heidelberg
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Recruitment hospital [11]
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Epworth Healthcare - Richmond
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Recruitment postcode(s) [1]
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- Garran
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- Camperdown
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- Kogarah
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- Saint Leonards
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- Westmead
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- Brisbane
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- Woodville South
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- Hobart
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- Box Hill
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- Heidelberg
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Recruitment postcode(s) [11]
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- Richmond
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Recruitment outside Australia
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California
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Colorado
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Achieve Life Sciences
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Ethics approval
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Summary
Brief summary
This Phase 3 study has been designed to confirm that adding custirsen to
cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes
compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate
resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter,
international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs.
cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal
probability to the two arms.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01578655
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Trial related presentations / publications
Saad F, Hotte S, North S, Eigl B, Chi K, Czaykowski P, Wood L, Pollak M, Berry S, Lattouf JB, Mukherjee SD, Gleave M, Winquist E; Canadian Uro-Oncology Group. Randomized phase II trial of Custirsen (OGX-011) in combination with docetaxel or mitoxantrone as second-line therapy in patients with metastatic castrate-resistant prostate cancer progressing after first-line docetaxel: CUOG trial P-06c. Clin Cancer Res. 2011 Sep 1;17(17):5765-73. doi: 10.1158/1078-0432.CCR-11-0859. Epub 2011 Jul 25.
Chi KN, Hotte SJ, Yu EY, Tu D, Eigl BJ, Tannock I, Saad F, North S, Powers J, Gleave ME, Eisenhauer EA. Randomized phase II study of docetaxel and prednisone with or without OGX-011 in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2010 Sep 20;28(27):4247-54. doi: 10.1200/JCO.2009.26.8771. Epub 2010 Aug 23.
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Public notes
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Contacts
Principal investigator
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Thomasz Beer, MD
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Oregon Health & Science University, Portland, Oregon
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01578655
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