AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer

RecruitingPhase 2Ages 18 Years - anyFemaleAlexander B Olawaiye, MD
💬

In plain words

What the trial is, and whether it could suit you

This Phase 2, open label, study with safety lead in of oral talazoparib in combination with ZEN003694 given daily in 28-day cycles will enroll patients with recurrent ovarian, fallopian tube or primary peritoneal carcinoma.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Females age ≥ 18 years (at time of signing informed consent) 2. ECOG status 0 or 1 3. Pathologically documented ovarian, fallopian tube, or primary peritoneal carcinoma. 4. Prior therapy with PARPi either as maintenance or therapeutic settings. 5. All recurrent ovarian cancer both platinum sensitive and platinum resistant are allowed. 6. Any prior number of cancer therapy regimens 7. Measurable disease per RECIST 1.1 8. Known BRCA1/2 status 9. Adequate laboratory parameters at Screening including: 1. Hemoglobin ≥ 9.0 gm/dL without transfusions during the 4 weeks prior to Screening 2. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L 3. Platelet count ≥ 150,000/mm3 4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.0 x ULN or if liver function abnormalities due to liver metastases AST and ALT ≤ 5.0 x ULN 5. Total bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN for subjects with known Gilbert's syndrome) 6. Serum Creatinine ≤ 1.5 X ULN 7. Prothrombin time (PT), international normalized ratio (INR) and partial thromboplastin time (PTT) \< 1.5 x ULN 10. Female subjects may be enrolled if they are not of childbearing potential, permanently sterile or who are post-menopausal, defined as no menses for at least 1 year without an alternative medical cause and FSH levels in the post-menopausal range. Female subjects of childbearing potential may be enrolled if they consistently and correctly use a highly effective form of contraception. Highly effective forms of contraception include: combined (estrogen and progestogen hormonal contraceptives (oral, intravaginal, transdermal) associated with inhibition of ovulation; progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence. Female subjects should not donate eggs from the time point of study drug administration until at least 7 months thereafter 11. Females of childbearing potential must have a negative serum pregnancy test before the first dose of study drug and must agree to serum pregnancy tests during the study. 12. Females may not be breast-feeding at the first dose of study drug, during study participation or through 7 months after the last dose of study drug. 13. Ability to swallow capsules and comply with study procedures. 14. Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures. 15. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable with evidence of no disease progression for 6 months. Exclusion Criteria: 16. Current or anticipated use of medications known to be strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows. Strong inhibitors, inducers or substrates must be discontinued at least 7 days prior to the first administration of study drug. 17. Current or anticipated use within 7 days prior to the first administration of study drug, or during the study, of strong P-gp inhibitors. 18. Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed 19. Radiation to \>25% of the bone marrow 20. Treatment with a bone-targeted radionuclide within 6 weeks of first dose of study drug 21. Prior chemotherapy or radiation within 3 weeks of study enrollment 22. Have previously received an investigational BET inhibitor (including previous participation in studies with Zenith drug, ZEN003694) 23. QTcF interval \> 470 msec 24. Insufficient recovery from prior treatment-related toxicities except for alopecia, fatigue and Grade 2 neuropathy 25. Non-healing wound, ulcer or bone fracture (not including a pathological bone fracture caused by a pre-existing pathological bone lesion) 26. Brain metastases not adequately treated and/or clinically stable (at the discretion of the Investigator) for at least 6 months prior to the start of study treatment. 27. Patients with ovarian carcinosarcoma 28. Known impaired cardiac function or clinically significant cardiac disease such as uncontrolled supraventricular arrhythmia, ventricular arrhythmia requiring therapy, or congestive heart failure (New York Heart Association functional class III or IV) 29. Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug 30. Known myelodysplastic syndrome 31. Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, or any other condition that could compromise safety or the patient's participation in the study 32. Impairment of gastrointestinal function that may significantly alter the absorption of ZEN003694 or talazoparib 33. Other known active cancer requiring therapy at time of study entry or that progressed or required treatment within 3 years prior to starting study drug (except for skin basal cell carcinoma or squamous cell carcinoma or in situ cervical cancer) 34. History of infection with (screening tests not required): human immunodeficiency virus; hepatitis B virus with currently active disease defined as hepatitis B surface antigen (HBsAg) positivity; or hepatitis C virus unless previously treated and viral load is undetectable except following situations: * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment are eligible for this trial. * Patients
💊

What it tests

  • ZEN003694
  • Talazoparib
📍

Where

1 site
University of Pittsburgh Medical Center
Pittsburgh, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy