A Phase I, 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 Identifier:
CC-94676-PCA-001
CT.gov Identifier:
NCT04428788
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Study Complete

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Study Summary

To assess the safety, tolerability, PK, PD and preliminary efficacy of CC-94676 in men with progressive metastatic castration-resistant prostate cancer.

To evaluate the safety and tolerability of escalating doses of CC-94676 in mCRCP subjects to determine the MTD of CC-94676.

To the safety and preliminary efficacy of CC-94676 administered at or below MTD in subjects with mCRPC.

To assess the safety, tolerability and preliminary efficacy of CC-94676 in men with progressive metastatic castration resistant prostate cancer.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Prostate
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Male
    Age
    18 - 100 Years
    Study Drug
  • Drug: Experimental: Administration of CC-94676, CC1083611, and CC1083610
    • Read More
  • Drug: Drug: CC1083611
  • Drug: Drug: CC1083610
  • Drug: Escalation doses evaluated were 100-1200 mg QD and 600-900 mg BID; expansion doses were 600 mg QD and 400-900 mg BID.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Nehal Lakhani
    Status
    Recruiting
    Condition(s) Treated at Site
    Prostate
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Drew Rasco
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Prostate