Talazoparib for Castration
Phase-Based Progress Estimates
Effectiveness
Safety
Castration+2 More
Talazoparib - DrugEligibility
18+
Male
What conditions do you have?
Select
Eligibility
18+
Male
What conditions do you have?
Select
Study Summary
This trial is testing the safety and effectiveness of combining these two drugs to treat prostate cancer.
Eligible Conditions
- Castration
- Malignant Neoplasms
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: Enrollment up to 2 years
Year 2
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Overall response rate (ORR)
Day 28
Rate of Dose Limiting Toxicity (DLT)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Dose Escalation Talazoparib + Tazemetostat
1 of 2
Dose Expansion Talazoparib + Tazemetostat
1 of 2
Experimental Treatment
38 Total Participants · 2 Treatment Groups
Primary Treatment: Talazoparib · No Placebo Group · Phase 1
Dose Escalation Talazoparib + TazemetostatExperimental Group · 2 Interventions: Talazoparib, Tazemetostat · Intervention Types: Drug, Drug
Dose Expansion Talazoparib + TazemetostatExperimental Group · 2 Interventions: Talazoparib, Tazemetostat · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
FDA approved
Tazemetostat
FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: enrollment up to 2 years
Who is running the clinical trial?
PfizerIndustry Sponsor
4,260 Previous Clinical Trials
7,104,881 Total Patients Enrolled
Epizyme, Inc.Industry Sponsor
30 Previous Clinical Trials
2,893 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,012 Previous Clinical Trials
393,321 Total Patients Enrolled
Atish Choudhury, MD PhDPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Eligibility Criteria
Age 18+ · Male Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have a performance status of 0 or 1 (i.e., no symptoms or mild symptoms).
You have a history of progression on at least one novel hormonal therapy in either the hormone-sensitive or castration-resistant disease setting.
A rising PSA value indicates prostate cancer.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments