Zn-c3-002: This clinical trial is trying to understand how safe, effective and well tolerated a new oral cancer drug is, in combination with chemotherapy, for the treatment of patients with ovarian, peritoneal or fallopian tube cancerA Phase 1b Study of ZN-c3 in Combination With Chemotherapy in Patients With Platinum-Resistant Ovarian, Peritoneal or Fallopian Tube Cancer

Exclusion

• 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.

  4. Inability to discontinue treatment for 5 half-lives or 14 days (whichever is longer) prior to Cycle 1 Day 1 with prescription or non-prescription drugs, or to discontinue consumption of food and herbal supplements, that are:

     • strong and moderate CYP3A inhibitors
     • strong and moderate CYP3A inducers
     • P-gp inhibitors

• 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 radiographically 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.
  6. Any evidence of small bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for small bowel obstruction within 3 months prior to Cycle 1 Day 1, or recurrent paracentesis or thoracentesis within 6 weeks prior to Cycle 1 Day 1.
• 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.