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

NCT03093272 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-04-09

Study results available
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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)

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Lauren C Harshman, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-23
Primary Completion
2019-05-16
Completion
2019-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03093272 on ClinicalTrials.gov