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.
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
Interventions
Drug | Synonyms | Arms |
---|
2X-121 | E7449, MGI25036 | 2X-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
Name | Type | Description | Interventions |
---|
2X-121 | Experimental | Oral administration of 2X-121 once daily as 600 mg hard gelatin capsules in a 28 days cycle. | |
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: | Allarity Therapeutics |
Last Updated
July 28, 2021