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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03093272
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Leuprolide Acetate — DRUG
    a GnRH agonist
  • Prednisone — DRUG
    Prednisone is a corticosteroid
  • Docetaxel — DRUG
    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.
  • Apalutamide — DRUG
    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

Study Details

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)

Key Dates

Start date
Jun 23, 2017
Status verified
Apr 2020
Primary completion
May 16, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ARN-509 Combined With Docetaxel
    * Apalutamide (ARN-509) will be taken orally at home daily * Docetaxel will be administered every 3 weeks intravenously * Prednisone will be taken orally twice daily * Leuprolide Acetate will be administered at the specification of the physician

Primary Outcome Measure

To Evaluate Progression-free Survival on the Combination of Docetaxel Plus Apalutamide [ Time Frame: Disease was evaluated radiologically at baseline and every 12 weeks on treatment; PFS follow up was up to 9.4 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-

Find similar trials in Boston, MA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Beth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MA

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