NCT03093272

A Study of Docetaxel + ARN-509 in Castration-Resistant Prostate Cancer

A Phase 2 Study of Docetaxel Plus Apalutamide in Castration-Resistant Prostate Cancer Patients Post Abiraterone Acetate

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Leuprolide Acetate	a GnRH agonist
DRUG	Prednisone	Prednisone is a corticosteroid
DRUG	Docetaxel	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.
DRUG	Apalutamide	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

Timeline

• Start date: 2017-06-23
• Primary completion: 2019-05-16
• Completion: 2019-12-31
• First posted: 2017-03-28
• Last updated: 2020-04-09
• Results posted: 2020-03-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study