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Trial ID:NCT04516447

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Protocol #:21-580

877-DF-TRIAL (877-338-7425)

Condition(s):Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Solid Tumor


Principal Investigator:Liu, Joyce, F

Site Research Nurse(s):Belavusava, Vera,
Bowes, Brittany, N.
Doherty, Kelsie,
Hindenach, Sarah,
Morrissey, Stephanie, C.
Neals, Allison,
Thistle, Katrina, M.

Trial Description:
This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of ZN-c3 in combination with other drugs.

Eligibility Requirements:
- Provision of written informed consent prior to initiation of any study-related procedures that are not considered standard of care.
- Females ≥ 18 years of age or the minimum legal adult age (whichever is greater) at the time of informed consent.
- ECOG performance status ≤ 2.
- Histologically or cytologically confirmed high-grade serous epithelial ovarian carcinoma, fallopian tube, or peritoneal carcinoma.
- Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the metastatic setting.
- The disease must be platinum-resistant, i.e., the Platinum-Free Interval (PFI) must have been < 6 months. Platinum refractory disease, i.e., PD during first-line platinum-based therapy is allowed.
- Measurable disease per RECIST version 1.1.
- Adequate hematologic and organ function as defined by the following criteria:
1. ANC ≥ 1.5 × 10^9/L; excluding measurements obtained within 7 days after daily administration of filgrastim/sargramostim or within 3 weeks after administration of pegfilgrastim.
2. Platelet count ≥ 100 × 10^9/L; excluding measurements obtained within 3 days after transfusion of platelets.
3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN). If liver function abnormalities are due to underlying liver metastases, AST and ALT ≤ 5 x ULN.
4. Total serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the case of Gilbert's disease.
5. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min.
- Female subjects of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test and agree to use an effective method of contraception per institutional standard.
- Left ventricular ejection fraction (LVEF) ≥ 50% or within normal limits of the institution (only for subjects treated with PLD).
Exclusion Criteria:
- Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
- Any of the following treatment interventions within the specified time frame prior to Cycle 1 Day 1:
1. Major surgery within 28 days.
2. Radiation therapy within 21 days.
3. Autologous or allogeneic stem cell transplant within 3 months.
- A serious illness or medical condition(s) including, but not limited to, the following:
1. Brain metastases that require immediate treatment or are clinically or radiologically unstable.
2. Leptomeningeal disease that requires or is anticipated to require immediate treatment.
3. Myocardial impairment of any cause.
4. Significant gastrointestinal abnormalities.
5. Active or uncontrolled infection.
- Unresolved toxicity of Grade > 1 attributed to any prior therapies (excluding Grade 2 neuropathy, alopecia or skin pigmentation).
- Pregnant or lactating females (including the cessation of lactation) or females of childbearing potential who have a positive serum pregnancy test within 14 days prior to Cycle 1 Day 1.
- Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
- 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of > 480 msec, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
- History or current evidence of congenital long QT syndrome.
- Taking medications that lead to significant QT prolongation.

Protocol #: 21-580

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