35 Participants Needed

Talazoparib + Tazemetostat for Prostate Cancer

Recruiting at 1 trial location
AC
Overseen ByAtish Choudhury, MD PhD
Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: Dana-Farber Cancer Institute
Must be taking: LHRH or GnRH agonists
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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:* Talazoparib* Tazemetostat

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications, but it does exclude participants taking certain medications that interact with the study drugs. You should discuss your current medications with the trial team to ensure there are no interactions.

What is known about the safety of Talazoparib for prostate cancer?

Talazoparib has shown antitumor activity with a manageable safety profile in men with metastatic castration-resistant prostate cancer, according to the TALAPRO-1 study.12345

What makes the drug combination of Talazoparib and Tazemetostat unique for prostate cancer treatment?

The combination of Talazoparib and Tazemetostat is unique because Talazoparib is a PARP inhibitor that targets DNA repair mechanisms, showing promise in prostate cancer with specific genetic alterations, while Tazemetostat is an EZH2 inhibitor, potentially enhancing the treatment's effectiveness by targeting cancer cell growth pathways.13467

What data supports the effectiveness of the drug combination Talazoparib and Tazemetostat for prostate cancer?

Talazoparib has shown antitumor activity in men with metastatic castration-resistant prostate cancer, particularly in those with DNA damage response alterations. It is also approved for treating certain types of breast cancer, indicating its potential effectiveness in targeting cancer cells.12346

Who Is on the Research Team?

Atish D. Choudhury, MD, PhD - Dana ...

Atish D. Choudhury

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am mostly able to carry out my daily activities.
I have been treated with a PARP inhibitor before.
My heart function is classified as class 2B or better according to the NYHA.
See 12 more

Exclusion Criteria

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.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Dose Escalation

Participants receive talazoparib and tazemetostat at a dose of 75% of the starting dose for their FDA-approved indications to find a safe dose

28 days per cycle
4 visits (in-person) per cycle

Dose Expansion

Participants receive talazoparib and tazemetostat at the safe dose identified in the dose escalation phase

28 days per cycle
4 visits (in-person) per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 24 months
Periodic visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Talazoparib
  • Tazemetostat
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Dose Expansion Talazoparib + TazemetostatExperimental Treatment2 Interventions
Group II: Dose Escalation Talazoparib + TazemetostatExperimental Treatment2 Interventions

Talazoparib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Talzenna for:
🇪🇺
Approved in European Union as Talzenna for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Epizyme, Inc.

Industry Sponsor

Trials
34
Recruited
2,800+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

The TALAPRO-2 trial is an ongoing study involving 1037 men with metastatic castration-resistant prostate cancer, testing the combination of talazoparib and enzalutamide to see if it improves survival without cancer progression compared to enzalutamide plus a placebo.
This trial aims to assess not only the efficacy of the drug combination but also the side effects experienced by participants, while also analyzing tumor DNA for faulty repair genes, which could provide insights into treatment responses.
Plain language summary of the design of the TALAPRO-2 study comparing talazoparib and enzalutamide versus enzalutamide and placebo in men with metastatic castration-resistant prostate cancer.Agarwal, N., Azad, A., Shore, ND., et al.[2022]
In the TALAPRO-1 study involving 97 men with metastatic castration-resistant prostate cancer (mCRPC), talazoparib significantly improved health-related quality of life (HRQoL) and reduced pain levels, particularly in patients with BRCA1/2 mutations.
The study found that 84% of all patients and 83% of those with BRCA1/2 mutations did not experience a deterioration in worst pain after 12 months of treatment, indicating a high probability of maintaining pain relief while receiving talazoparib.
Patient-reported Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Harboring DNA Damage Response Alterations Treated with Talazoparib: Results from TALAPRO-1.Saad, F., de Bono, J., Barthélémy, P., et al.[2023]
Talazoparib is an oral PARP inhibitor recently approved in the USA for treating adults with specific types of breast cancer, particularly those with BRCA mutations, highlighting its targeted efficacy in a defined patient population.
The drug is also being explored for use in other cancers, including metastatic castration-resistant prostate cancer and early triple negative breast cancer, indicating its potential versatility in cancer treatment.
Talazoparib: First Global Approval.Hoy, SM.[2020]

Citations

Plain language summary of the design of the TALAPRO-2 study comparing talazoparib and enzalutamide versus enzalutamide and placebo in men with metastatic castration-resistant prostate cancer. [2022]
Patient-reported Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Harboring DNA Damage Response Alterations Treated with Talazoparib: Results from TALAPRO-1. [2023]
Talazoparib: First Global Approval. [2020]
A phase I trial of talazoparib and irinotecan with and without temozolomide in children and young adults with recurrent or refractory solid malignancies. [2021]
Talazoparib, a Poly(ADP-ribose) Polymerase Inhibitor, for Metastatic Castration-resistant Prostate Cancer and DNA Damage Response Alterations: TALAPRO-1 Safety Analyses. [2023]
Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: TALAPRO-2 phase III study design. [2022]
Characteristics, Treatment, and Outcomes of Real-World Talazoparib-Treated Patients With Germline BRCA-Mutated Advanced HER2-Negative Breast Cancer. [2023]
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