NCT02207504

Crizotinib in Combination With Enzalutamide in Metastatic Castration-resistant Prostate Cancer

A Phase 1 Study of Crizotinib in Combination With Enzalutamide in Metastatic Castration-resistant Prostate Cancer Before or After Progression on Docetaxel.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is comparing the combination of drugs Crizotinib and Enzalutamide as a possible treatment for metastatic castration-resistant prostate cancer (mCRPC).

Detailed description

* A traditional 3+3 dose escalation scheme will be used to identify the recommended phase 2 dose (RP2D) of crizotinib when used in combination with standard fixed dose enzalutamide. * Patients who fulfill eligibility criteria will be entered into the trial to receive crizotinib and enzalutamide. * After the screening procedures confirm participation in the research study: * The participant will be given a study drug-dosing calendar for each treatment cycle. The investigators are looking for the highest dose of the combination of study drugs that can be administered safely without severe or unmanageable side effects in participants that have, not everyone who participates in this research study will receive the same dose of the study drug. The dose given will depend on the number of participants who have been enrolled in the study prior and how well the dose was tolerated.

Conditions

• Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Crizotinib	Crizotinib is an ATP-competitive small-molecule inhibitor of the ALK, c-Met/HGFR, RON, and ROS receptor tyrosine kinases.
DRUG	Enzalutamide	Enzalutamide is an androgen receptor signaling inhibitor.

Timeline

• Start date: 2014-08-01
• Primary completion: 2018-02-02
• Completion: 2022-01-03
• First posted: 2014-08-04
• Last updated: 2022-01-06

Locations

1 site across 1 country: United States