Clinical trial NCT04428788: Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Prostatic Neoplasms
Keywords: Prostate Cancer
CC-94676
Castration-resistant prostate cancer
Adenocarcinoma of the prostate
Prostatic Neoplasms Castration-Resistant
Neoplasms
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria
timeFrame: From the time of consent at screening until 28 days after thesubject discontinues study treatment.
measure: Dose-limiting toxicity (DLT)
timeFrame: Up to 35 days
measure: Non-tolerated dose (NTD)
timeFrame: Up to 35 days
measure: Maximum tolerated dose (MTD)
timeFrame: Up to 35 days
Secondary outcomes:
measure: Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)
timeFrame: Up to approximately 4 years
measure: Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
timeFrame: Up to approximately 4 years
measure: Duration of response (DOR)
timeFrame: Up to approximately 4 years
measure: Proportion of participants alive and not progressed at 6 months
timeFrame: Up to 6 months after treatment is discontinued
measure: PSA Progression Free Survival (PFS)
timeFrame: Up to approximately 4 years
measure: Radiographic progression free survival (rPFS)
timeFrame: Up to approximately 4 years
measure: Overall survival (OS)
timeFrame: Up to approximately 4 years
measure: Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population
timeFrame: Up to approximately 4 years
measure: Pharmacokinetics - Area under the plasma concentration time curve (AUC)
timeFrame: Up to 35 days
measure: Pharmacokinetics - Maximum plasma concentration (Cmax)
timeFrame: Up to 35 days
measure: Pharmacokinetics - Time to Cmax (Tmax)
timeFrame: Up to 35 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Local Institution - 116
state: California
city: Washington
country: United States
facility: Local Institution - 122
state: District of Columbia
city: Sarasota
country: United States
facility: Local Institution - 103
state: Florida
city: Thomasville
country: United States
facility: Local Institution - 121
state: Georgia
city: Baltimore
country: United States
facility: Local Institution - 108
state: Maryland
city: Boston
country: United States
facility: Local Institution - 104
state: Massachusetts
city: Ann Arbor
country: United States
facility: Local Institution - 117
state: Michigan
city: Grand Rapids
country: United States
facility: Local Institution - 102
state: Michigan
city: New York
country: United States
facility: Local Institution - 112
state: New York
city: New York
country: United States
facility: Local Institution - 109
state: New York
city: New York
country: United States
facility: Local Institution - 105
state: New York
city: Durham
country: United States
facility: Local Institution - 106
state: North Carolina
city: Allentown
country: United States
facility: Local Institution - 120
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution - 113
state: Pennsylvania
city: Dallas
country: United States
facility: Local Institution - 107
state: Texas
city: Houston
country: United States
facility: Local Institution - 119
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 101
state: Texas
city: Seattle
country: United States
facility: Local Institution - 115
state: Washington
city: Madison
country: United States
facility: Local Institution - 111
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: