Ovarian Cancer study: ZEN003694 vs Talazoparib
Official title ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer
ClinicalTrials.gov ID: NCT05071937
What this study is testing
What is ZEN003694?
An investigational oral medicine being studied for the treatment of recurrent ovarian, fallopian tube, or primary peritoneal carcinoma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how safe and effective the combination of ZEN003694 and talazoparib is for people whose cancer has returned.
- Who it's for
- Adults who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.
- What's involved
- Participants will take oral talazoparib and ZEN003694 every day in 28‑day cycles, with regular clinic visits and medical tests to monitor safety and response.
- Time commitment
- The study continues until the cancer progresses or the participant stops; it involves daily medication and periodic clinic visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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.
You likely can't join if
- Current or anticipated use of medications known to be strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic...
- 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...
- Radiation to \>25% of the bone marrow
- Treatment with a bone-targeted radionuclide within 6 weeks of first dose of study drug
- Prior chemotherapy or radiation within 3 weeks of study enrollment
See the full eligibility criteria
Who can join
- 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
- 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 people 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 people 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...
- 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...
What rules you out
- Current or anticipated use of medications known to be strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows.
- 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
- Treatment with a bone-targeted radionuclide within 6 weeks of first dose of study drug
- Prior chemotherapy or radiation within 3 weeks of study enrollment
- Have previously received an investigational BET inhibitor (including previous participation in studies with Zenith drug, ZEN003694)
- QTcF interval \> 470 msec
- Insufficient recovery from prior treatment-related toxicities except for alopecia, fatigue and Grade 2 neuropathy
- Non-healing wound, ulcer or bone fracture (not including a pathological bone fracture caused by a pre-existing pathological bone lesion)
- 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.
- Patients with ovarian carcinosarcoma
- 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...
- Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug
- Known myelodysplastic syndrome
- 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...
- Impairment of gastrointestinal function that may significantly alter the absorption of ZEN003694 or talazoparib
- 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...
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment are eligible for this trial.
- Patients with a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection are allowed to be...
- Major surgery other than diagnostic surgery, dental surgery or stenting within 4 weeks prior to the first administration of study drug
- Concurrent participation in another clinical investigational treatment trial
- Any other reason that in the opinion of the Investigator would prevent the patient from completing participation or following the study schedule
The study team makes the final eligibility decision.
Where it is enrolling
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.