Actively Recruiting
ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer
Led by Alexander B Olawaiye, MD · Updated on 2025-06-22
33
Participants Needed
1
Research Sites
514 weeks
Total Duration
On this page
Sponsors
A
Alexander B Olawaiye, MD
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, age 18 years or older
- ECOG performance status of 0 or 1
- Pathologically confirmed ovarian, fallopian tube, or primary peritoneal carcinoma
- Prior treatment with a PARP inhibitor in maintenance or therapeutic settings
- Recurrent ovarian cancer, including both platinum-sensitive and platinum-resistant cases
- Any number of prior cancer therapy regimens
- Measurable disease according to RECIST 1.1 criteria
- Known BRCA1/2 mutation status
- Adequate laboratory test results including hemoglobin, neutrophils, platelets, liver and kidney function, and coagulation parameters
- Female participants must be post-menopausal, permanently sterile, or using highly effective contraception if of childbearing potential
- Negative serum pregnancy test prior to first study drug dose for females of childbearing potential
- Not breastfeeding at first dose and during study participation through 7 months after last dose
- Ability to swallow capsules and comply with study procedures
- Ability to understand and sign informed consent
- Patients with treated and stable brain metastases meeting specified criteria
You will not qualify if you...
- Use of strong CYP3A4 or CYP1A2 interacting medications within 7 days prior to study drug administration
- Use of strong P-glycoprotein inhibitors within 7 days prior to or during the study
- Use of oral Factor Xa or Factor IIa inhibitors (some exceptions apply)
- Radiation treatment to more than 25% of bone marrow
- Treatment with bone-targeted radionuclides within 6 weeks prior to first dose
- Chemotherapy or radiation within 3 weeks before enrollment
- Prior treatment with investigational BET inhibitors including ZEN003694
- QTcF interval over 470 msec
- Incomplete recovery from prior treatment toxicities except certain conditions
- Non-healing wounds, ulcers, or bone fractures (excluding pathological fractures due to lesions)
- Untreated or unstable brain metastases
- Diagnosis of ovarian carcinosarcoma
- Significant cardiac disease or recent heart attack
- Known myelodysplastic syndrome
- Serious uncontrolled medical conditions or infections
- Gastrointestinal issues affecting drug absorption
- Other active cancers requiring therapy or recent progression
- History of certain viral infections unless well controlled
- Major surgery within 4 weeks prior to study drug
- Concurrent participation in another investigational treatment trial
- Other conditions preventing study compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
K
Kelsey Mitch, BSN
CONTACT
L
Lucia Borasso, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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