NCT01828476

Navitoclax and Abiraterone Acetate With or Without Hydroxychloroquine in Treating Patients With Progressive Metastatic Castrate Refractory Prostate Cancer

A Phase II Study of ABT-263/Abiraterone (Arm A) or ABT-263/Abiraterone and Hydroxychloroquine (Arm B) in Patients With Metastatic Castrate Refractory Prostate Cancer (CRPC) and Progression Following Chemotherapy and Abiraterone

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effect of combining abiraterone with medicines that may block some of the ways that cells become resistant to abiraterone. The investigators hope that these combinations of medicines will result in prostrate cancer cells dying. This study will see if overcoming diseases resistance to abiraterone will restore sensitivity to androgen deprivation therapy.

Detailed description

Subjects will be either treated on one of the earlier dosing regimens or randomly assigned to one of two groups or ARMs of this study. ARM A will receive Abiraterone with ABT-263. ARM B will receive Abiraterone with both ABT-263 and Hydroxychloroquine In the beginning of the study a total of 18 patients may get one of three dose levels. A total of nine (9) patients per each arm will be started at a low dose and given increasing doses if no side effects are seen. In this part of the study three patients will be enrolled at each dose level for each individual arm starting with Arm A followed by Arm B.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Abiraterone	ARM A(Abiraterone with ABT-263) and ARM B(Abiraterone with both ABT-263 and Hydroxychloroquine)
DRUG	ABT-263	ARM A(Abiraterone with ABT-263) and ARM B(Abiraterone with both ABT-263 and Hydroxychloroquine)
DRUG	Hydroxychloroquine	ARM B(Abiraterone with both ABT-263 and Hydroxychloroquine)

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-02-01
• Completion: 2016-03-03
• First posted: 2013-04-10
• Last updated: 2017-05-04
• Results posted: 2017-03-31

Locations

1 site across 1 country: United States