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Small Molecule Inhibitor
PLX2853 for Prostate Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Opna-IO LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years at the time of signing informed consent.
Histologically confirmed adenocarcinoma of the prostate with tumor tissue available for molecular analyses.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of first dose until completion of long term follow-up, approximately 30 months.
Awards & highlights
Study Summary
This study is evaluating whether a drug may help treat prostate cancer.
Eligible Conditions
- Prostate Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of first dose until completion of long term follow-up, approximately 30 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of first dose until completion of long term follow-up, approximately 30 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Phase 1b (both arms): Incidence of dose-limiting-toxicities (DLTs)
Disease
Secondary outcome measures
Upper arm
Upper arm
Duration of Response (DOR) (both arms, both phases)
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: PLX2853 + OlaparibExperimental Treatment2 Interventions
Phase 1b (PLX2853 + Olaparib Combination): Up to 18 evaluable subjects with homologous recombination repair (HRR) gene-mutated mCRPC will be enrolled.
Phase 2a (PLX2853 + Olaparib Combination): Up to 58 evaluable subjects with homologous recombination repair (HRR) gene-mutated mCRPC will be enrolled.
Group II: PLX2853 + Abiraterone Acetate + PrednisoneExperimental Treatment3 Interventions
Phase 1b (PLX2853 + Abiraterone Acetate + Prednisone Combination): Up to 15 evaluable subjects with mCRPC will be enrolled.
Phase 2a (PLX2853 + Abiraterone Acetate + Prednisone Combination): Up to 19 evaluable subjects with mCRPC will be enrolled.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone acetate
2014
Completed Phase 3
~3440
Olaparib
2007
Completed Phase 4
~2140
PLX2853
2019
Completed Phase 1
~80
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
Opna-IO LLCLead Sponsor
3 Previous Clinical Trials
108 Total Patients Enrolled
PlexxikonLead Sponsor
24 Previous Clinical Trials
1,082 Total Patients Enrolled
1 Trials studying Prostate Cancer
6 Patients Enrolled for Prostate Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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