A Phase 1, Multi-center, Open-label, Dose Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cc-94676 in Subjects With Metastatic Castration-resistant Prostate Cancer

Celgene19 sites in 1 country131 target enrollmentJune 22, 2020

ConditionsProstatic Neoplasms

InterventionsCC-94676 CC1083611 CC1083610

Overview

Phase: Phase 1
Intervention: CC-94676
Conditions: Prostatic Neoplasms
Sponsor: Celgene
Enrollment: 131
Locations: 19
Primary Endpoint: Non-tolerated dose (NTD)
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety, tolerability and preliminary efficacy of CC-94676 in men with progressive metastatic castration resistant prostate cancer.

Registry

clinicaltrials.gov

Start Date

June 22, 2020

End Date

October 28, 2025

Last Updated

4 months ago

Study Type

Interventional

Study Design

Sequential

Sex

Male

Investigators

Sponsor

Celgene

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must have histologically or cytologically confirmed adenocarcinoma of the prostate
•Progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria

•Prior treatment with an androgen receptor (AR) degrader
•Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 1 year prior to the first dose of IP
•Clinically significant venous thromboembolism within 3 months prior to the first dose of IP
•Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness
•Other protocol-defined inclusion/exclusion criteria apply

Arms & Interventions

Administration of CC-94676, CC1083611, and CC1083610

Intervention: CC-94676

Administration of CC-94676, CC1083611, and CC1083610

Intervention: CC1083611

Administration of CC-94676, CC1083611, and CC1083610

Intervention: CC1083610

Outcomes

Primary Outcomes

Non-tolerated dose (NTD)

Time Frame: Up to 35 days

Maximum tolerated dose (MTD)

Time Frame: Up to 35 days

Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria

Time Frame: From the time of consent at screening until 28 days after thesubject discontinues study treatment.

Dose-limiting toxicity (DLT)

Time Frame: Up to 35 days

Secondary Outcomes

Overall survival (OS)(Up to approximately 4 years)
Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)(Up to approximately 4 years)
Proportion of participants alive and not progressed at 6 months(Up to 6 months after treatment is discontinued)
Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)(Up to approximately 4 years)
PSA Progression Free Survival (PFS)(Up to approximately 4 years)
Pharmacokinetics - Area under the plasma concentration time curve (AUC)(Up to 35 days)
Duration of response (DOR)(Up to approximately 4 years)
Radiographic progression free survival (rPFS)(Up to approximately 4 years)
Pharmacokinetics - Maximum plasma concentration (Cmax)(Up to 35 days)
Pharmacokinetics - Time to Cmax (Tmax)(Up to 35 days)
Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population(Up to approximately 4 years)