Clinical Trials Logo

Clinical Trial Summary

This is a two-arm, open label Phase 1b/2 study with an oral administration of CPI-1205 in combination with either enzalutamide or abiraterone/prednisone in male patients with metastatic Castration Resistant Prostate Cancer. This study is designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) based on safety, tolerability, pharmacokinetic, and efficacy profiles of CPI-1205 in combination with either enzalutamide or abiraterone/prednisone. Following determination of MTD and RP2D will proceed to phase 2. Patients in phase 2 will receive CPI-1205 at the RP2D in combination with either enzalutamide or abiraterone/prednisone vs either enzalutamide or abiraterone/prednisone as a control arm.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03480646
Study type Interventional
Source Constellation Pharmaceuticals
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date November 15, 2017
Completion date December 2021

See also
  Status Clinical Trial Phase
Terminated NCT05208229 - The Role of WB-MRI in the Evaluation of Prostate Cancer Patients Treated With Lutetium - Prostate Specific Membrane Antigen (Lu-PSMA)
Suspended NCT05425862 - Pidnarulex and Talazoparib in Patients With Metastatic Castration Resistant Prostate Cancer Phase 1
Recruiting NCT03874884 - 177Lu-PSMA-617 Therapy and Olaparib in Patients With Metastatic Castration Resistant Prostate Cancer Phase 1
Terminated NCT03549000 - A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies. Phase 1
Completed NCT05701007 - Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland
Terminated NCT04052204 - Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03724747 - Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Antitumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate Alone and in Combination With Darolutamide, in Patients With Metastatic Castration Resistant Prostate Cancer Phase 1
Completed NCT04516161 - EPIX, a Study to Gather More Information About Characteristics of Patients and Other Factors Which May Contribute to Survival Over a Long Period of Time in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo)
Withdrawn NCT02130947 - Exercise Intervention for Pts With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or Enzalutamide N/A