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



Status:Recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/20/2019
Start Date:March 2019
End Date:March 2022
Contact:USA: Christin Whalen, RN
Email:christin_whalen@DFCI.HARVARD.EDU
Phone:+617-582-1138

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Phase II, Prospective Open Label, Single Arm Study to Investigate Anti-tumor Effect and Tolerability 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 once 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.


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
We found this trial at
1
site
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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