Study on ZEN003694 and Talazoparib for Patients with Recurrent Ovarian Cancer

Sponsor: Alexander B Olawaiye, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05071937

Provider View

This clinical trial is testing a combination of two drugs, ZEN003694 and talazoparib, to see if they can help treat women with ovarian, fallopian tube, or primary peritoneal cancer that has come back after previous treatments.

Patient Parameters

Program Overview

This Phase 2 study is open to women with recurrent ovarian, fallopian tube, or primary peritoneal cancer. It will test the safety and effectiveness of taking ZEN003694 and talazoparib together in 28-day cycles. The study aims to see how well these drugs work in stopping cancer growth and if they are safe for patients to use.

Description

The study is exploring the combination of two drugs, ZEN003694 and talazoparib, to see if they can effectively treat recurrent ovarian cancer. ZEN003694 is being developed to stop cancer cells from multiplying, while talazoparib works by blocking an enzyme called PARP, which is involved in cancer development. Although these drugs are not yet approved for ovarian cancer, they have shown promise in treating other types of cancer. The study will monitor how patients respond to the treatment and any side effects they experience.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Have a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer.
  • Have previously been treated with a PARP inhibitor.
  • Cancer has returned, whether it is sensitive or resistant to platinum-based treatments.
  • Have had any number of previous cancer treatments.
  • Have measurable cancer according to specific criteria.
  • Know their BRCA1/2 genetic status.
  • Meet certain blood test requirements, including:
    • Hemoglobin level of at least 9.0 gm/dL without recent transfusions.
    • Neutrophil count of at least 1.5 x 10^9/L.
    • Platelet count of at least 150,000/mm3.
    • Liver enzymes and bilirubin within specified limits.
    • Kidney function within specified limits.
    • Blood clotting times within specified limits.
  • Women must not be able to become pregnant or must use effective birth control during the study and for 7 months after.
  • Must not be breastfeeding during the study and for 7 months after.
  • Able to swallow capsules and follow study procedures.
  • Understand and agree to sign a consent form.
  • If they have had brain metastases, they must have completed treatment and be stable for at least 6 months.

Exclusion Criteria

  • Use of certain medications that affect liver enzymes or blood clotting within 7 days before starting the study.
  • Use of certain blood thinners, except for low molecular weight heparin.
  • Recent radiation to a large portion of the bone marrow.
  • Recent treatment with bone-targeted radionuclides.
  • Recent chemotherapy or radiation within 3 weeks before starting the study.
  • Previous treatment with a BET inhibitor.
  • Heart rhythm issues or heart disease.
  • Recent heart attack or unstable chest pain.
  • Other active cancers requiring treatment.
  • Serious infections or other medical conditions that could affect safety or participation.
  • Gastrointestinal issues affecting drug absorption.
  • Recent major surgery.
  • Participation in another clinical trial.
  • Any other reason deemed by the investigator that could prevent study completion.

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