Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer

Korábbi kezelés

• Concurrent chemotherapy, antibody therapies radiotherapy,hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period.
• Clinically significant cardiovascular disease:
  • Stroke within ≤ 12 months prior to day 1
  • Transient ischemic attach (TIA) within ≤ 12 months prior to day 1
  • Myocardial infarction within ≤ 12 months prior to day 1
  • Unstable angina
  • New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF)
  • Uncontrolled cardiac arrhythmia requiring medication
• Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy.
• Ascites requiring drainage >500cc in the 2 weeks prior to enrolment.

Más betegség

• Patients who have platinum-refractory disease, defined as progression during the last platinum-based chemotherapy.
• Other malignancy with exception of any stage I and II cancer that is deemed cured by the Investigator.
• Any active infection requiring parenteral or oral antibiotic treatment.
• Known HIV positivity.
• Known active hepatitis B or C.
• Other medications or conditions that in the Investigator's opinion would contraindicate study participation for safety reasons or interfere with the interpretation of study results.
• Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of 2X-121.

Egyéb

• Patients unable to be regularly followed for any reason (geographic, familiar, social, psychological, housed in an institution e.g., prison because of a court agreement or administrative order).
• Patients, who are close colleagues, associates, or family members of, or in any way dependent on the sponsor or the investigator.

• Signed informed consent form.
• Age 18 years or older.
• Histologically or cytologically documented epithelial ovarian, fallopian tube, or primary peritoneal tumors, with high-grade serous or endometrioid, or predominantly serous/endometrioid histology (independent of BRCA1 and HRD status).
• Patients must have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible.
• Patients have received no more than one line of therapy in the platinum resistant or platinum ineligible setting. Note: Prior ADCs therapy (e.g., Elahere) will not count towards this previous line of therapy.
• Measurable disease by CT scan or MRI. Note: Baseline tumor assessment will be performed within 4 weeks prior to Day 1 Cycle 1
• Performance status of ECOG ≤ 1.
• Patients must have a life expectancy of >16 weeks.
• Recovered to Grade 1 or less from prior surgery or acute toxicities of prior radiotherapy, or treatment with cytotoxic, hormonal, or biologic agents.
• Adequate conditions as evidenced by the following clinical laboratory values:
  • Absolute neutrophils count (ANC) ≥ 1.5 x 103 μL
  • Hemoglobin > 9.0 g/dL
  • Platelets ≥ 100 x 103 μL
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase ≤ 2.5 x ULN, unless liver metastases are present, in which case they must be ≤5 x ULN
  • Serum bilirubin ≤ 1.5 ULN
  • Creatinine ≤ 1.5 ULN
  • Blood urea nitrogen (BUN) ≤2X ULN.
• FFPE tumor tissue should be available from the current relapse, if obtainable, otherwise the most recent archival tumor tissue. Note: Patients treated with a PARP inhibitor must have a new biopsy unless there is an archival biopsy that was done after the PARP inhibitor treatment was discontinued.
• Negative serum pregnancy test in women of childbearing potential (WOCBP). WOCBP is defined as premenopausal women or less than 12 months of amenorrhea post-menopause, and women who have not undergone surgical sterilization or hysterectomy or bilateral salpingo-oophorectomy.
• Sexually active females of childbearing potential must use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception) for the study duration and at least six months afterwards.