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.
Morrissey, Stephanie, C.
Thistle, Katrina, M.
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.
- 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
- 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
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).
- Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline
- 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
1. Brain metastases that require immediate treatment or are clinically or
2. Leptomeningeal disease that requires or is anticipated to require immediate
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
- 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