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

This study is to be performed as an open label, multicenter, single arm study of 2X-121 to evaluate anti-tumor efficacy of 2X-121 as single agent therapy in a 28-days cycle in advanced ovarian cancer patients. 2X-121 will be supplied for oral administration twice daily as 600 mg (3 x 200 mg) capsules in a 28 days cycle. Patients with predicted high likelihood of responding to the drug (2X-121) using drug response prediction (DRP®), will be included in the study.


Eligibility Criteria:
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