PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

  • STATUS
    Recruiting
  • End date
    Mar 30, 2023
  • participants needed
    110
  • sponsor
    Plexxikon
Updated on 26 June 2021

Summary

The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Details
Condition Metastatic Castration Resistant Prostate Cancer
Treatment prednisone, olaparib, abiraterone acetate, PLX2853
Clinical Study IdentifierNCT04556617
SponsorPlexxikon
Last Modified on26 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years at the time of signing informed consent
Histologically confirmed adenocarcinoma of the prostate with tumor tissue available for molecular analyses
Eastern Cooperative Oncology Group Performance Status 0 to 1
Adequate organ function as demonstrated following laboratory values
Fertile male subjects with female sexual partners must agree to use a highly effective method of birth control during the study and for 90 days after the last dose of study drug
Except as specified above for organ function, all drug-related toxicity from previous cancer therapy (including ongoing Abiraterone Acetate + Prednisone therapy if applicable) must be resolved (to Grade 1 or baseline per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0) prior to study treatment administration (Grade 2: alopecia, hot flashes, decreased libido, or neuropathy is allowed)
Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements

Exclusion Criteria

Prior exposure to a bromodomain inhibitor
History of autoimmune hemolytic anemia or autoimmune thrombocytopenia
Clinically significant cardiac disease
Inability to take oral medication or significant nausea and vomiting, malabsorption, or significant small bowel resection that, in the opinion of the Investigator, would preclude adequate absorption
Active known second malignancy with the exception of any of the following
Adequately treated basal cell carcinoma or squamous cell carcinoma of the skin
Adequately treated Stage I cancer from which the subject is currently in remission and has been in remission for 2 years
Any other cancer from which the subject has been disease-free for 3 years
Subject is participating in any other therapeutic clinical study (observational or registry studies are allowed)
Presence of any other medical, psychological, familial, sociological, or geographic condition potentially hampering compliance with the study protocol or would interfere with the study endpoints or the subject's ability to participate in the study in the judgment of the Investigator
Receipt of any anti-cancer therapy prior to Cycle 1 Day 1 with less than protocol defined wash-out with the exception of Abiraterone Acetate (for subjects enrolling into Abiraterone Acetate Combination) and GnRH therapy
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