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

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ClinicalTrials.gov Identifier: NCT04428788
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Celgene

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 Intervention/treatment Phase
Prostatic Neoplasms Drug: CC-94676 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
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 22, 2020
Estimated Primary Completion Date : June 28, 2022
Estimated Study Completion Date : June 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428788


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

Locations
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United States, Florida
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
United States, Texas
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Marie Nguyen, MD Celgene
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04428788    
Other Study ID Numbers: CC-94676-PCA-001
U1111-1251-9174 ( Other Identifier: WHO )
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Prostate Cancer
CC-94676
Castration-resistant prostate cancer
Adenocarcinoma of the prostate
Prostatic Neoplasms Castration-Resistant
Neoplasms
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases