Phase ll Study of a BET Inhibitor, ZEN003694, Combined With a PARP Inhibitor, Talazoparib, in Patients With Recurrent Ovarian Cancer
Alexander B Olawaiye, MD
Summary
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.
Description
This study aims to determine how effective the combination of ZEN003694 and talazoparib is based on how patients respond. ZEN003694 (and developed by Zenith Epigenetics Ltd.) has shown promising activity in the treatment of solid tumors and hematologic (blood) cancers by reducing the multiplication of cancer cells. Talazoparib is an extremely effective drug being developed for the treatment of a variety of human cancers. Talazoparib kills cancer cells by inhibiting and trapping the enzyme PARP, which is known to be involved in the development of many types of cancers. These two drugs are not F…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 pri…
Interventions
- DrugZEN003694
ZEN003694 has shown promising activity in the treatment of solid tumors and hematologic (blood) cancers by reducing the multiplication of cancer cells.
- DrugTalazoparib
Talazoparib kills cancer cells by inhibiting and trapping the enzyme PARP, which is known to be involved in the development of many types of cancers.
Location
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania