ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAlexander B Olawaiye, MD
About this trial
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.
Eligibility criteria
Qualifiers
Females age ≥ 18 years (at time of signing informed consent)
ECOG status 0 or 1
Pathologically documented ovarian, fallopian tube, or primary peritoneal carcinoma.
Prior therapy with PARPi either as maintenance or therapeutic settings.
Disqualifiers
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.
Current or anticipated use within 7 days prior to the first administration of study drug, or during the study, of strong P-gp inhibitors.
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
Radiation to >25% of the bone marrow
Trial design
Treatments tested in this trial
- ZEN003694
- Talazoparib
Treatment groups
33 Participants
are divided into 1 treatment groupSponsors and collaborators
Alexander B Olawaiye, MD
Lead sponsor
University of Pittsburgh
Sponsor institution
Pfizer
Collaborator
Zenith Epigenetics
Collaborator
Source ClinicalTrials.gov