Clinical trial NCT04556617: PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Official title: A Multicenter, Open-Label, Parallel, Phase 1b/2a Study of PLX2853 in Combination With Abiraterone Acetate and Prednisone and Phase 1b/2a Study of PLX2853 in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Metastatic Castration-resistant Prostate Cancer
Keywords: PLX2853
Metastatic Castration-resistant Prostate Cancer
Olaparib
Abiraterone Acetate
Adenocarcinoma
Prostate Cancer
Lead sponsor: Opna Bio LLC
Sponsor class: INDUSTRY
First posted: 2020-09-21
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years at the time of signing informed consent.
2. Histologically confirmed adenocarcinoma of the prostate with tumor tissue available for molecular analyses.
3. Eastern Cooperative Oncology Group Performance Status 0 to 1.
4. Adequate organ function as demonstrated following laboratory values.
5. 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.
6. 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).
7. Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements.

Exclusion Criteria:

1. Prior exposure to a bromodomain inhibitor.
2. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
3. Clinically significant cardiac disease.
4. 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.
5. 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.
6. Subject is participating in any other therapeutic clinical study (observational or registry studies are allowed).
7. 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.
8. 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.

Primary outcomes:
measure: Number of Participants With Dose-Limiting Toxicities
timeFrame: From time of first dose of PLX2853 and combination agent(s) through completion of Cycle 1 (21 days)
measure: Phase 1b (Both Arms): Incidence of TEAEs That Are Related to Treatment
timeFrame: From time of first dose of PLX2853 and combination agent(s) until 30 days from end of treatment (an average of 103 days)
measure: Determination of Maximum Tolerated Dose
timeFrame: From time of first dose of PLX2853 and combination agent(s) through completion of Cycle 1 (21 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Oncology/ Sarah Cannon
state: Tennessee
city: Fairfax
country: United States
facility: Virginia Cancer Specialist
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute
Study officials:
References: