Study on the Effects of Talazoparib in Patients with Advanced Cancer and DNA Repair Variations

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04550494

Provider View

This clinical trial is exploring whether the drug talazoparib can help treat advanced cancers that have spread and have specific DNA repair gene mutations. The study includes patients who have or have not been treated with other similar drugs before.

Patient Parameters

Program Overview

This phase II study is testing if talazoparib, a drug that blocks a protein called PARP, can help treat advanced cancers with specific DNA repair gene mutations. PARP helps repair damaged DNA, and blocking it may prevent cancer cells from fixing their DNA, causing them to die. This trial will help researchers understand if using different PARP inhibitors one after the other is beneficial and how talazoparib works in these patients.

Description

The main goal of this study is to see how talazoparib affects tumors in patients with specific DNA repair gene mutations, whether or not they have used other PARP inhibitors before. Researchers will also look at how well the cancer responds to the treatment and explore any genetic changes in the tumors that might affect how well talazoparib works.

Participants will take talazoparib by mouth once a day in 28-day cycles, as long as the cancer does not worsen or cause severe side effects. Throughout the study, patients will have biopsies, blood tests, and scans like CT or MRI to monitor their progress. After finishing the treatment, patients will have a follow-up visit 30 days later.

Eligibility Criteria

Inclusion Criteria

  • Adults with solid tumors and specific DNA repair gene mutations, whose cancer has worsened after standard treatment or who have no other treatment options.
  • Must have certain genetic mutations that suggest sensitivity to PARP inhibitors, with no more than 6 patients having the same mutation.
  • Must be 18 years or older.
  • Must be in good overall health with a performance status score of 0 to 2.
  • Must have a life expectancy of more than 3 months.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Must have measurable cancer that can be tracked using standard criteria.
  • Must have a tumor that can be biopsied.
  • Women of childbearing potential must use effective contraception during and for 7 months after treatment. Men must use contraception during and for 4 months after treatment.
  • Must be able to swallow tablets or capsules.
  • Must understand and agree to sign informed consent.
  • Must have recurrent, locally advanced, or metastatic cancer.
  • Must have progressed after at least one standard treatment, except for those without standard options or for whom talazoparib is standard.
  • Specific criteria for patients with ovarian, pancreatic, breast, gastric, and prostate cancer regarding prior treatments and disease status.

Exclusion Criteria

  • Recent chemotherapy or radiotherapy within 4 weeks or 5 half-lives, whichever is shorter.
  • Previous treatment with talazoparib.
  • Recent monoclonal antibody therapy unless proven safe with PARP inhibitors.
  • Use of other investigational drugs.
  • Active brain metastases or cancer spread to the brain lining, unless stable for at least 1 month without medication.
  • Uncontrolled illnesses or conditions that would interfere with the study.
  • Pregnant or breastfeeding women.
  • HIV-positive patients on effective treatment with undetectable viral load are eligible.
  • Use of certain blood thinners like warfarin, except low-dose.
  • History of other cancers within the past 3 years, except controlled non-melanoma skin cancers.

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