A Study of Docetaxel + ARN-509 in Castration-Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03093272|
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : July 16, 2018
This research study is studying a combination of drugs as a possible treatment for castration-resistant prostate cancer.
The interventions involved in this study are:
- Docetaxel (a type of chemotherapy)
- Apalutamide (the study medication, also known as ARN-509)
- Prednisone (a corticosteroid given to prevent reactions to docetaxel).
- Leuprolide acetate (also known as Lupron, a GnRH agonist or similar drug which is standard of care, causes chemical castration which greatly lowers the level of testosterone in the body)
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Leuprolide Acetate Drug: Prednisone Drug: Docetaxel Drug: Apalutamide||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
Apalutamide is considered an investigational product, which is believed to reduce the growth of prostate cancer cells. The FDA (the U.S. Food and Drug Administration) has not approved apalutamide as a treatment for any disease, but it is being studied in prostate cancer. Docetaxel is an approved therapy for this type of cancer. The FDA has not approved the combination of the two drugs in any use.
In this research study, the investigators are evaluating the combination of two drugs, docetaxel with apalutamide. The investigators will keep track of participants' prostate-specific antigen (PSA), scans, and overall health to determine how well this drug combination works at treating this type of cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Docetaxel Plus Apalutamide in Castration-Resistant Prostate Cancer Patients Post Abiraterone Acetate|
|Actual Study Start Date :||June 23, 2017|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||August 31, 2024|
Experimental: ARN-509 Combined With Docetaxel
Drug: Leuprolide Acetate
a GnRH agonist
Other Name: Lupron Injection
Prednisone is a corticosteroid
Other Name: Deltasone
Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly.
The apalutamide drug substance is an almost white to slightly brown powder. The tablet formulation of apalutamide is an immediate release oral tablet containing 60-mg of drug substance, with a non-functional green film coat
Other Name: ARN-509
- Progression Free Survival [ Time Frame: 4 months ]To evaluate progression-free survival on the combination of docetaxel plus apalutamide
- Incidence of Treatment-Emergent Adverse Events according to NCI CTCAE v4.0 [ Time Frame: 2 years ]All adverse events recorded during the trial that are new or worsening from the time of first dose of treatment will be summarized for the safety population.
- Dose-Limiting Toxicities in the Safety Lead-in Group (first 6 patients) [ Time Frame: 6 months ]Specific adverse events will be recorded during the safety lead-in phase of 6 patients. Any toxicities considered unacceptable during this time will be considered a dose-limiting toxicity and will be summarized among all patients evaluable for a dose-limiting toxicity.
- Maximum Blood Concentration (Cmax) for Docetaxel Pharmacokinetic Analysis [ Time Frame: 2 years ]Maximum blood concentration (Cmax) and time of maximum blood concentration (tmax) will be determined by visual inspection.
- Area Under the Curve (AUC) for Docetaxel Pharmacokinetic Analysis [ Time Frame: 2 years ]The area under the blood concentration-time curve (linear trapezoidal rule) will be determined between 0-24 hours (AUC0-24).
- Time to Progression [ Time Frame: 2 years ]Radiologic time to progression and PSA progression will be analyzed using the Kaplan-Meier Method.
- Time to Treatment Failure [ Time Frame: 2 years ]Time to treatment failure (including progression and intolerability) will be analyzed using the Kaplan-Meier Method.
- Objective Response Rate [ Time Frame: 2 years ]Objective Response Rate
- PSA Response [ Time Frame: 2 years ]Will be assessed according to Prostate Cancer Working Group 2 criteria
- Serum PSA Change From Baseline [ Time Frame: 12 weeks ]The maximum percent PSA change (rise or fall) from baseline to after 12 weeks on study. It will be summarized using box-whisker plots and waterfall plots for each treatment arm.
- Overall Survival [ Time Frame: 2 years ]Overall Survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093272
|Contact: Lauren C Harshman, MD||617-632-4524||LaurenC_Harshman@dfci.harvard.edu|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Glenn Bubley, MD 617-735-2062|
|Principal Investigator: Glenn Bubley, MD|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Lauren C Harshman, MD 617-632-4524 LaurenC_Harshman@dfci.harvard.edu|
|Principal Investigator: Lauren C Harshman, MD|
|Principal Investigator:||Lauren C Harshman, MD||Dana-Farber Cancer Institute|