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PARP Inhibitor
Talazoparib + Tazemetostat for Prostate Cancer
Phase 1
Recruiting
Led By Atish Choudhury, MD PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤1 (Karnofsky ≥70%, see Appendix A)
Age ≥18 years. Children under 18 are excluded from this study as prostate cancer is a disease of adults
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment up to 2 years
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of combining these two drugs to treat prostate cancer.
Who is the study for?
Adult men with advanced prostate cancer that has spread and is worsening, despite previous hormone therapy. They must be able to swallow pills, have good organ function, agree to use contraception, and undergo a biopsy for genetic testing. Men with HIV or hepatitis can join if well-controlled. Excluded are those on certain other drugs, with recent thrombosis, uncontrolled illnesses, brain metastases or another active cancer.Check my eligibility
What is being tested?
The trial tests combining talazoparib and tazemetostat—oral medications targeting specific molecular pathways in prostate cancer cells—to see if they're safe together and effective against metastatic prostate cancer.See study design
What are the potential side effects?
Potential side effects of talazoparib include anemia, nausea, fatigue; while tazemetostat may cause tiredness, muscle pain. Both drugs could potentially affect blood counts and liver enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly able to carry out my daily activities.
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I am 18 years old or older.
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I agree to use effective birth control during and 6 months after the study.
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I have previously been treated with a newer hormone therapy for my prostate cancer.
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My blood and organ functions meet the required levels for the trial.
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I have prostate cancer with worsening signs, either through rising PSA levels or worsening scans.
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I can swallow pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Rate of Dose Limiting Toxicity (DLT)
Secondary outcome measures
Overall response rate (ORR)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose Expansion Talazoparib + TazemetostatExperimental Treatment2 Interventions
Participants will receive talazoparib and tazemetostat at the safe dose identified in the first part (dose escalation) of the study.
During each 28 day study treatment cycle participants will take:
Talazoparib once daily.
Tazemetostat twice daily.
Group II: Dose Escalation Talazoparib + TazemetostatExperimental Treatment2 Interventions
Standard 3+3 dose escalation will be followed, participants will initially receive talazoparib and tazemetostat at a dose of 75% of the starting dose for their FDA-approved indications.
During each 28 day study treatment cycle participants will take:
Talazoparib once daily.
Tazemetostat twice daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
2016
Completed Phase 2
~780
Talazoparib
2021
Completed Phase 2
~2770
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,948 Total Patients Enrolled
77 Trials studying Prostate Cancer
16,105 Patients Enrolled for Prostate Cancer
Epizyme, Inc.Industry Sponsor
33 Previous Clinical Trials
2,888 Total Patients Enrolled
1 Trials studying Prostate Cancer
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,947 Total Patients Enrolled
42 Trials studying Prostate Cancer
12,369 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am mostly able to carry out my daily activities.I have been treated with a PARP inhibitor before.I haven't had chemotherapy, experimental treatments, or radiotherapy in the last 4 weeks.I haven't taken any cancer pills like hormone therapy or experimental drugs in the last 14 days.I do not have brain metastases or leptomeningeal disease.My heart function is classified as class 2B or better according to the NYHA.I have another cancer but it's either in remission, treated, not needing treatment for 2 years, or a non-serious skin cancer.I am 18 years old or older.I agree to have a biopsy for advanced testing after 8 weeks of treatment.I am not taking specific heart, infection, or fungus medications that could interfere with the trial.I agree to use effective birth control during and 6 months after the study.I have been treated with an EZH2 inhibitor before.You have had allergic reactions to similar drugs like talazoparib or tazemetostat.I had hepatitis C but am cured, or if currently treated, my viral load is undetectable without drug conflicts.I don't have major side effects from previous cancer treatments, except for manageable ones like hair loss or tiredness.I do not have any uncontrolled illnesses like heart failure or ongoing infections.I have had a blood clot in the last 3 months.I have previously been treated with a newer hormone therapy for my prostate cancer.My blood and organ functions meet the required levels for the trial.I have metastatic cancer with low testosterone and can measure my cancer's response.I am scheduled for a biopsy before starting treatment, but it can be waived due to COVID-19.My hepatitis B is under control and the medication I take doesn't interfere with the trial drugs.I am not pregnant or nursing, as this study is for prostate cancer.I have prostate cancer with worsening signs, either through rising PSA levels or worsening scans.You are not currently taking any experimental medications for other research studies.I can swallow pills.I am HIV positive, on effective treatment, with an undetectable viral load.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation Talazoparib + Tazemetostat
- Group 2: Dose Expansion Talazoparib + Tazemetostat
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings remaining in this clinical trial?
"According to clinicaltrials.gov, the search for participants for this medical trial is ongoing since it was listed on June 28th 2021 and last modified July 18th of 2022."
Answered by AI
What conditions can Talazopab typically ameliorate?
"Patients with brca1 gene mutations, metastatic epithelioid sarcoma, or malignant neoplasms can be administered Talazoparib to manage their condition."
Answered by AI
What is the highest number of participants that can be enrolled in this clinical experiment?
"Affirmative. Clinicaltrials.gov outlines that this clinical trial, first published on June 28th 2021 is still recruiting and requires 38 patients from two different research centers to complete the study."
Answered by AI
Could you please provide a summary of past research conducted with Talazoparib?
"Currently, 5 Phase 3 trials involving Talazoparib are underway. With the majority of studies centred in Boston, Massachusetts there is a significant reach with 3629 operating sites globally."
Answered by AI
To what extent might Talazoparib have an adverse impact on individuals?
"There is limited clinical data surrounding talazoparib's safety and efficacy, thus receiving a score of 1."
Answered by AI
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