Investigation of 2X-121 in Patients With Advanced Ovarian Cancer Selected by the 2X-121 DRP® (PREDICT 2X-121)

This is an interventional treatment trial for Advanced Ovarian Cancer Read More

Inclusion Criteria:

• Signed informed consent form
• Age 18 years or older
• Histologically or cytological documented ovarian carcinoma with ≥ 2 or more previous chemotherapies including potential treatment with other PARP inhibitors (PARPi)
• Platinum free interval of ≥ 3 month
• Measurable disease by CT scan or MRI
• A 2X-121 DRP® using Fixed in Formalin and Embedded in Paraffin (FFPE) archival or the latest tumor tissue with an outcome measured as being in the upper 50% likelihood of response
• 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 and protocol values of the following clinical laboratory parameters:

  1. Absolute neutrophils count
  2. Hemoglobin
  3. Platelets
  4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
  5. Serum bilirubin
  6. Alkaline phosphatase
  7. Creatinine
  8. Blood urea within normal limits
• FFPEs tumor tissue should be available either from primary surgery or later
• Negative serum pregnancy test in women of childbearing potential (WOCBP).
• Women of childbearing age and potential must be willing to use adequate effective contraception during the study and a period after last dose of study drug

Exclusion Criteria:

• Currently participating in or having participated in a study of an investigational agent or using an investigational device within 2 weeks of giving informed consent
• Concurrent chemotherapy, radiotherapy, or hormonal therapy for the disease under investigation
• Other malignancy with exception of any stage I and II cancer that is deemed cured or deemed not to influence the overall survival by the Investigator
• Any active infection still requiring parenteral or oral antibiotic treatment
• Known HIV positivity
• Known active hepatitis B or C

• Clinical significant (i.e. active) cardiovascular disease:

  1. Stroke within ≤ 6 months prior to day 1
  2. Transient ischemic attack (TIA) within ≤ 6 months prior to day 1
  3. Myocardial infarction within ≤ 6 months prior to day 1
  4. Unstable angina
  5. New York Hart Association (NYHA) Grade II or greater congestive heart failure (CHF)
  6. Serious cardiac arrhythmia requiring medication
• Other medications or conditions that in the investigator's opinion would contraindicate study participation of 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, diarrhoea, or vomiting) that might impair the bioavailability of 2X-121
• Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy
• Patients unable to be regularly followed for any reason (geographic, familiar, social, psychologic, housed in an institution eg. prison because of a court agreement or administrative order)
• Subjects that are depending on the sponsor/CRO or investigational site as well as on the investigator