Facebook Icon Print Created with Sketch. Twitter Icon Created with Sketch. Created with Sketch. LinkedIn Icon Green Check Icon Created with Sketch. YouTube Icon Right Arrow Icon Mobile Menu Icon Chevron Right Icon Phone Icon Health Study Area: AutoImmune Disease Health Study Area: AutoImmune Disease Health Study Area: Blood Cancer Health Study Area: Blood Cancer Health Study Area: Cardiovascular Disease Health Study Area: Cardiovascular Disease Health Study Area: Fibrosis Health Study Area: Fibrosis Health Study Area: Gastrointestinal Cancer Health Study Area: Gastrointestinal Cancer Health Study Area: Genitourinary Health Study Area: Genitourinary Health Study Area: Head and Neck Cancer Health Study Area: Head and Neck Cancer Health Study Area: Lung Cancer Health Study Area: Lung Cancer Health Study Area: Melanoma Health Study Area: Melanoma Health Study Area: Women's Cancer Health Study Area: Breast Cancer Health Study Area: Breast Cancer For Caregivers For Caregivers For Clinicians Communities FAQs For Parents For Parents For Patients For Patients Chevron Icon Bookmark Icon Map Icon Share Icon Direction Arrow Icon Direction Arrow Icon Page Icon Location Icon Search Icon External Link Icon Help Icon Help Icon Error Icon Glossary Email Icon Gender Both Gender Both Gender Male Gender Female Created with Sketch. Created with Sketch. Health Study Area: NASH Instagram Created with sketchtool. For Clinicians

Please Log In/Join Now first, and then use this function!

Recruiting

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-94676 in Subjects With Metastatic Castration-Resistant Prostate Cancer - CC-94676-PCA-001

Updated: 5 May, 2021   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 6

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Administration of CC-94676
Drug: CC-94676

Key Eligibility Criteria

Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is a male ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Subjects must have histologically or cytologically confirmed adenocarcinoma of the prostate. 3. Subjects must have documented progressive metastatic castration-resistant prostate cancer (CRPC). 4. Subjects must have progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for CRPC (eg, abiraterone, enzalutamide, apalutamide, or darolutamide). 5. Subjects must have serum testosterone ≤ 50 ng/dL. Subjects must continue primary androgen deprivation with a luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) if they have not undergone bilateral orchiectomy. 6. Subjects must have discontinued bicalutamide ≥ 6 weeks prior to the first dose of CC-94676. Subjects must have discontinued abiraterone, rucaparib, or olaparib ≥ 2 weeks prior to the first dose of CC-94676. Subjects must have discontinued enzalutamide, flutamide, nilutamide, and other approved secondary hormonal therapy, chemotherapy, immunotherapy, or investigational treatments (except treatments to maintain castrate status) > 4 weeks prior to the first dose of CC-94676. Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment: 1. Subject has confirmed or suspected small cell carcinoma of the prostate/neuroendocrine prostate cancer. 2. Subject currently has symptomatic brain or epidural central nervous system (CNS) or spinal metastases requiring steroids (above physiologic replacement doses) or radiation. 3. Subject had palliative radiation, strontium-89, or radium-223 ≤ 4 weeks prior to the first dose of CC-94676. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study, as long as this is not a sign of clinically significant disease progression. 4. Subject has any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com