A Study Evaluating the Pain Palliation Benefit of Adding Custirsen to Docetaxel Retreatment or Cabazitaxel as Second Line Therapy in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)
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ClinicalTrials.gov Identifier: NCT01083615 |
Recruitment Status
:
Terminated
(Unable to enroll due to criteria for stable baseline pain)
First Posted
: March 10, 2010
Last Update Posted
: October 12, 2016
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Tracking Information | ||||||||||
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First Submitted Date ICMJE | February 26, 2010 | |||||||||
First Posted Date ICMJE | March 10, 2010 | |||||||||
Last Update Posted Date | October 12, 2016 | |||||||||
Study Start Date ICMJE | March 2010 | |||||||||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
To ascertain whether the investigational arm has a greater proportion of patients with durable pain palliation as compared to the control arm. [ Time Frame: 3 to 6 months ] | |||||||||
Original Primary Outcome Measures ICMJE |
To ascertain whether the investigational arm has a greater proportion of patients with durable pain palliation as compared to the control arm. [ Time Frame: 12 weeks ] | |||||||||
Change History | Complete list of historical versions of study NCT01083615 on ClinicalTrials.gov Archive Site | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
Current Other Outcome Measures ICMJE | Not Provided | |||||||||
Original Other Outcome Measures ICMJE | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | A Study Evaluating the Pain Palliation Benefit of Adding Custirsen to Docetaxel Retreatment or Cabazitaxel as Second Line Therapy in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC) | |||||||||
Official Title ICMJE | A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating the Pain Palliation Benefit of Adding Custirsen to a Taxane for Second-Line Chemotherapy in Men With Castrate Resistance Prostate Cancer | |||||||||
Brief Summary | The purpose of this study is to determine if the addition of study drug (custirsen) can provide durable pain palliation for castrate resistant prostate cancer patients receiving docetaxel retreatment or cabazitaxel as a second line therapy. | |||||||||
Detailed Description | This is a randomized, double-blind, placebo-controlled, multicenter, international trial enrolling patients with metastatic CRPC who had a response to first-line docetaxel therapy and have prostate cancer-related pain with progression of disease. The intended intervention is second-line treatment with docetaxel retreatment or cabazitaxel plus study agent, where custirsen is to be administered in the investigational arm and placebo is to be administered in the control arm. Selection of the chemotherapy (docetaxel re-treatment or cabazitaxel) is to be determined by the treating physician, based on the patient's first-line response. The study will primarily assess pain and analgesic use for evaluation of durable pain palliation in response to study treatment. Pain and analgesic use will be obtained via a 3rd party contact center (direct contact with patient). Study treatment starts with a Loading Dose Period during which three infusions of study agent (custirsen vs. placebo) will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel or cabazitaxel on a 21-day cycle with weekly study agent (custirsen vs. placebo) infusions on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID. Patients will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol. If study treatment is completed or discontinued prior to pain progression, 6-day assessments will continue every 3 weeks until pain progression is documented. Follow-up after study treatment will occur for safety parameters for 3 weeks after the last study agent infusion in all patients. Survival status updates are to be reported every 12 weeks following documentation of pain progression. The amount of time that patients remain on the study will vary; but the average survival of these patients who receive second line taxane treatment is expected to be 14 to 15 months. |
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Study Type ICMJE | Interventional | |||||||||
Study Phase | Phase 3 | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Terminated | |||||||||
Actual Enrollment ICMJE |
14 | |||||||||
Original Estimated Enrollment ICMJE |
292 | |||||||||
Actual Study Completion Date | March 2013 | |||||||||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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Sex/Gender |
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Ages | 18 Years to 99 Years (Adult, Senior) | |||||||||
Accepts Healthy Volunteers | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | Canada, France, Spain, United Kingdom, United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT01083615 | |||||||||
Other Study ID Numbers ICMJE | OGX-011-10 | |||||||||
Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||
IPD Sharing Statement | Not Provided | |||||||||
Responsible Party | Achieve Life Sciences | |||||||||
Study Sponsor ICMJE | Achieve Life Sciences | |||||||||
Collaborators ICMJE | Teva Pharmaceuticals USA | |||||||||
Investigators ICMJE |
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PRS Account | Achieve Life Sciences | |||||||||
Verification Date | October 2016 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |