Phase Ia/Ib Talazoparib + Tazemetostat for mCRPC
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ClinicalTrials.gov Identifier: NCT04846478 |
Recruitment Status :
Active, not recruiting
First Posted : April 15, 2021
Last Update Posted : April 26, 2024
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | April 13, 2021 | ||||||||||||||
First Posted Date ICMJE | April 15, 2021 | ||||||||||||||
Last Update Posted Date | April 26, 2024 | ||||||||||||||
Actual Study Start Date ICMJE | June 28, 2021 | ||||||||||||||
Estimated Primary Completion Date | March 30, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
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Current Secondary Outcome Measures ICMJE |
Overall response rate (ORR) [ Time Frame: Enrollment up to 2 years ] Assessed by RECIST 1.1 and/or prostate-specific antigen (PSA) reduction by ≥ 50%
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Phase Ia/Ib Talazoparib + Tazemetostat for mCRPC | ||||||||||||||
Official Title ICMJE | A Phase Ia/Ib Study of Talazoparib in Combination With Tazemetostat in Metastatic Castration-resistant Prostate Cancer (mCRPC) | ||||||||||||||
Brief Summary | This trial is testing whether molecularly targeted oral medications called talazoparib and tazemetostat can be safely combined for the treatment of prostate cancer, and whether the combination is effective in shrinking or preventing the growth of metastatic prostate cancer. The names of the study drugs involved in this study are:
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Detailed Description | This is a Phase 1a/1b clinical trial to assess safety, tolerability and preliminary clinical activity of the combination of talazoparib with tazemetostat in metastatic castration-resistant prostate cancer (mCRPC) patients. The U.S. Food and Drug Administration (FDA) has not approved talazoparib or tazemetostat for metastatic castration-resistant prostate cancer (mCRPC) but they have been approved for other uses. Talazoparib has been approved for use in breast cancer, and tazemetostat has been approved for use in certain types of sarcoma and lymphoma. Talazoparib is an orally administered molecularly targeted chemotherapy drug called a "PARP inhibitor", which acts to block the ability of cancer cells to repair certain forms of damage to their DNA - the accumulation of damaged DNA causes certain cancer cells to die. Other PARP inhibitors are already approved for use in prostate cancer patients with specific gene mutations detected in their blood or in their cancer, and talazoparib is currently being studied for treatment of prostate cancer in other clinical trials. Tazemetostat is an orally administered molecularly targeted chemotherapy drug called an "EZH2 inhibitor", which acts to block the production of proteins encoded by DNA in the cancer cells that are important in cancer growth and survival. Tazemetostat is also being studied for the treatment of prostate cancer in other clinical trials. In the laboratory setting, tazemetostat causes changes in protein levels in prostate cancer cells that make them sensitive to dying in the presence of PARP inhibitors. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. The study design involves two parts. The first part is called the "dose escalation" to find a safe dose for the combination of talazoparib and tazemetostat. The second part is called the "dose expansion" where additional participants are treated at the safe dose identified in the first part of the study. Participants will receive study treatment for as long as they do not have serious side effects and their disease does not get worse. Participants will be followed after completion of study treatment for up to 24 months. It is expected that about 38 people will take part in this research study. Funding for this research is provided by a grant awarded by the non-profit Prostate Cancer Foundation along with Pfizer, Inc. In addition, Pfizer is supporting the study by providing the study drug talazoparib. Epizyme, Inc. is supporting the study by providing the study drug tazemetostat. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||
Actual Enrollment ICMJE |
35 | ||||||||||||||
Original Estimated Enrollment ICMJE |
38 | ||||||||||||||
Estimated Study Completion Date ICMJE | September 30, 2025 | ||||||||||||||
Estimated Primary Completion Date | March 30, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04846478 | ||||||||||||||
Other Study ID Numbers ICMJE | 21-086 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Atish Choudhury, MD, Dana-Farber Cancer Institute | ||||||||||||||
Original Responsible Party | Atish Choudhury, Dana-Farber Cancer Institute, Principal Investigator | ||||||||||||||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||||
Verification Date | April 2024 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |