Phase ll Study of a BET Inhibitor, ZEN003694, Combined With a PARP Inhibitor, Talazoparib, in Patients With Recurrent Ovarian Cancer

Who is this study for? Patients with Ovarian, Peritoneal Cancer
What treatments are being studied? ZEN003694+Talazoparib
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• All recurrent ovarian cancer both platinum sensitive and platinum resistant are allowed.

• Any prior number of cancer therapy regimens

• Measurable disease per RECIST 1.1

• Known BRCA1/2 status

• Adequate laboratory parameters at Screening including:

∙ Hemoglobin ≥ 9.0 gm/dL without transfusions during the 4 weeks prior to Screening

‣ Absolute neutrophil count (ANC) ≥ 1.5 × 109/L

‣ Platelet count ≥ 150,000/mm3

‣ 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

‣ Total bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN for subjects with known Gilbert's syndrome)

‣ Serum Creatinine ≤ 1.5 X ULN

‣ Prothrombin time (PT), international normalized ratio (INR) and partial thromboplastin time (PTT) \< 1.5 x ULN

⁃ 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

⁃ 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.

⁃ 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.

⁃ Ability to swallow capsules and comply with study procedures.

⁃ Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures.

⁃ 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.

Locations
United States
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Contact Information
Primary
Kelsey Mitch, BSN
adamikka2@upmc.edu
412-648-6417
Backup
Lucia Borasso, BSN
borrlm@upmc.edu
412-641-3304
Time Frame
Start Date: 2023-04-21
Estimated Completion Date: 2033-03-01
Participants
Target number of participants: 33
Treatments
Experimental: ZEN003694 + Talazoparib
ZEN003694: 48.0 mg daily (oral) in 28-day cycles~Talazoparib: 0.75 mg daily (oral) at the same time as ZEN003694
Related Therapeutic Areas
Sponsors
Leads: Alexander B Olawaiye, MD
Collaborators: Zenith Epigenetics, Pfizer

This content was sourced from clinicaltrials.gov