Clinical Trials /

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

NCT03878849

Description:

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.

Related Conditions:
  • Ovarian Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Investigation of 2X-121 in Patients With Advanced Ovarian Cancer Selected by the 2X-121 DRP®
  • Official Title: 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®

Clinical Trial IDs

  • ORG STUDY ID: (PARPi) 2X-1002
  • SECONDARY ID: 2018-003341-41
  • NCT ID: NCT03878849

Conditions

  • Advanced Ovarian Cancer

Interventions

DrugSynonymsArms
2X-121E7449, MGI250362X-121

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
2X-121ExperimentalOral administration of 2X-121 once daily as 600 mg hard gelatin capsules in a 28 days cycle.
  • 2X-121

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:evaluated after up to approximately 2 years
Safety Issue:
Description:defined as complete response (CR) or partial response (PR) using the RECIST criteria version 1.1

Secondary Outcome Measures

Measure:Clinical benefit rate (CBR)
Time Frame:evaluated after up to approximately 2 years
Safety Issue:
Description:defined as complete response (CR) and partial response (PR) or stable disease (SD) for > 16 weeks using the RECIST criteria version 1.1
Measure:Progression free survival
Time Frame:evaluated after up to approximately 2 years
Safety Issue:
Description:from baseline to progression or death
Measure:Duration of response
Time Frame:evaluated after up to approximately 2 years
Safety Issue:
Description:from first response to progression
Measure:Overall survival
Time Frame:evaluated after up to approximately 2 years
Safety Issue:
Description:from baseline until death
Measure:Quality of Life measurement
Time Frame:at baseline and start of each cycle, up to approximately 2 years
Safety Issue:
Description:evaluated by Quality of Life Questionnaires (QLQ) QLQ-C30 Version 3.0, EORTC QLQ-OV 28 and MOST Version 2.0
Measure:Correlation between 2X-121 DRP® and clinical outcome
Time Frame:evaluated after up to approximately 2 years
Safety Issue:
Description:comparing the DRP levels in the different response groups

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Oncology Venture

Last Updated

October 26, 2020