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

  • Clinicaltrials.gov identifier

    NCT04428788

  • Recruitment Status

    Recruiting

  • First Posted

    June 11, 2020

  • Last update posted

    May 6, 2021

Study Description

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.

  • Condition or Disease:Prostatic Neoplasms
  • Intervention/Treatment: Drug: CC-94676
  • Phase: Phase 1

Detailed Description

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.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 60 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: June 2020
  • Estimated Primary Completion Date: June 2022
  • Estimated Study Completion Date: June 2022

Arms and interventions

Arm Intervention/treatment
Experimental: Administration of CC-94676
Escalating doses of CC-94676 administered orally (tablets) once daily.
Drug: CC-94676
CC-94676

Outcome Measures

  • Primary Outcome Measures: 1. Adverse Events (AEs) [ Time Frame: From the time of consent at screening until 28 days after the subject discontinues study treatment. ]
    Type, frequency, seriousness, severity and relationship of AEs to CC-94676.
  • 2. Dose-limiting Toxicities (DLTs) [ Time Frame: Up to 35 days ]
    Number of subjects with a DLT.
  • 3. Non-Tolerated Dose (NTD) [ Time Frame: Up to 35 days ]
    The dose of CC-94676 associated with unacceptable safety and tolerability.
  • 4. Maximum Tolerated Dose (MTD) [ Time Frame: Up to 35 days ]
    The highest dose of CC-94676 associated with acceptable safety and tolerability.
  • Secondary Outcome Measures: 1. Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50) [ Time Frame: Up to approximately 4 years ]
    is defined as a ≥ 50% reduction in PSA from baseline to the lowest postbaseline PSA value and required confirmation by a consecutive assessment at least 3 weeks later (PSA50).
  • 2. Objective soft tissue response [ Time Frame: Up to approximately 4 years ]
    The proportion of subjects who achieve a best response of partial response or better (PR or CR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
  • 3. Duration of response (DOR) [ Time Frame: Up to approximately 4 years ]
    is defined as the time from the earliest date of documented soft tissue response (PR or CR based on PCWG3) to the first documented soft tissue disease progression or death, whichever occurs first.
  • 4. Proportion of subjects alive and not progressed at 6 months [ Time Frame: Up to 6 months after treatment is discontinued ]
    The proportion of subjects alive and who have not progressed at 6 months follow-up with progression defined by PCWG3.
  • 5. PSA Progression Free Survival (PFS) [ Time Frame: Up to approximately 4 years ]
    PSA PFS will be calculated for all treated subjects as, after a decline from baseline, the time from the first dose of CC-94676 to the first PSA increase that is ≥ 25% and a ≥ 2 ng/mL above the nadir, and which is confirmed by a second value ≥ 3 weeks later. When there is no decline from baseline, then PSA progression is ≥ 25% increase and a ≥ 2 ng/mL increase from baseline beyond 12 weeks.
  • 6. Radiographic progression free survival (rPFS) [ Time Frame: Up to approximately 4 years ]
    The time from the first dose of CC-94676 to the first objective evidence of radiographic progression or death from any cause, whichever occurs first.
  • 7. Overall survival (OS) [ Time Frame: Up to approximately 4 years ]
    OS is the time from the first dose of CC-94676 to death from any cause.
  • 8. Overall Survival (OS) rate [ Time Frame: Up to approximately 4 years ]
    will be summarized using the Kaplan-Meier method for the treated population.
  • 9. Pharmacokinetics - AUC [ Time Frame: Up to 35 days ]
    Area under the plasma concentration time curve
  • 10. Pharmacokinetics - Cmax [ Time Frame: Up to 35 days ]
    Maximum plasma concentration
  • 11. Pharmacokinetics - Tmax [ Time Frame: Up to 35 days ]
    Time to Cmax
  • 12. Pharmacokinetics - t1/2 [ Time Frame: Up to 35 days ]
    Terminal half-life
  • 13. Pharmacokinetics - CL/F [ Time Frame: Up to 35 days ]
    Apparent total clearance of the drug from plasma after oral administration
  • 14. Pharmacokinetics - Vz/F [ Time Frame: Up to 35 days ]
    Apparent volume of distribution during terminal phase after oral administration

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations

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

Sponsors and Collaborators

Celgene

Investigators

Study Director: Marie Nguyen, MD Celgene

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT04428788 History of Changes
  • Other Study ID Numbers: CC-94676-PCA-001, U1111-1251-9174
  • First Posted: June 11, 2020 Key Record Dates
  • Last Update Posted: May 6, 2021
  • Last Verified: April 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: See Plan Description
  • Access Criteria: See Plan Description
  • URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Neoplasms
    Prostatic Neoplasms Castration-Resistant
    Adenocarcinoma of the prostate
    Castration-resistant prostate cancer
    CC-94676
    Prostate Cancer
  • Additional relevant MeSH terms: Neoplasms Prostatic Neoplasms