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NCT04428788
Recruiting
June 11, 2020
May 6, 2021
Brief summary:
This is a first in human study to assess the safety, tolerability, PK, PD and preliminary efficacy of CC-94676 in men with progressive metastatic castration-resistant prostate cancer.
Study CC-94676-PCA-001 is a first-in-human dose finding study to determine the safety, tolerability, PK, PD, and preliminary efficacy of CC-94676 in subjects with mCRPC who have progressed on ADT and at least one prior secondary hormonal therapy approved for CRPC (eg, abiraterone, enzalutamide, apalutamide, or darolutamide). The dose escalation will evaluate the safety and tolerability of escalating doses of CC-94676 in mCRCP subjects to determine the MTD of CC-94676. The dose expansion will further evaluate the safety and preliminary efficacy of CC-94676 administered at or below MTD in subjects with mCRPC.
| Arm | Intervention/treatment |
|---|---|
| Experimental: Administration of CC-94676 Escalating doses of CC-94676 administered orally (tablets) once daily. |
Drug: CC-94676 CC-94676 |
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.
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com
United States, Florida
Florida Cancer Specialists
Sarasota
United States, Massachusetts
Dana Farber Cancer Institute
Boston
United States, Michigan
START Midwest
Grand Rapids
United States, New York
Memorial Sloan-Kettering Cancer Center
New York
United States, North Carolina
Duke University Medical Center
Durham
United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio
Celgene
Study Director: Marie Nguyen, MD Celgene
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