Status:
RECRUITING
Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer
Lead Sponsor:
Allarity Therapeutics
Collaborating Sponsors:
Alcedis GmbH
Amarex Clinical Research
Conditions:
Advanced Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the optimal dose of 2X-121 as single agent therapy at 600 mg daily (split BID 200 mg morning + 400 mg evening) compared to 800 mg daily (split BID 400 mg morni...
Eligibility Criteria
Inclusion
- Signed informed consent form.
- Age 18 years or older.
- Histologically or cytologically documented epithelial ovarian, fallopian tube, or primary peritoneal tumors, with high-grade serous or endometrioid, or predominantly serous/endometrioid histology (independent of BRCA1 and HRD status).
- Patients must have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible.
- Patients have received no more than one line of therapy in the platinum resistant or platinum ineligible setting. Note: Prior ADCs therapy (e.g., Elahere) will not count towards this previous line of therapy.
- Measurable disease by CT scan or MRI. Note: Baseline tumor assessment will be performed within 4 weeks prior to Day 1 Cycle 1
- 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 as evidenced by the following clinical laboratory values:
- Absolute neutrophils count (ANC) ≥ 1.5 x 103 μL
- Hemoglobin \> 9.0 g/dL
- Platelets ≥ 100 x 103 μL
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase ≤ 2.5 x ULN, unless liver metastases are present, in which case they must be ≤5 x ULN
- Serum bilirubin ≤ 1.5 ULN
- Creatinine ≤ 1.5 ULN
- Blood urea nitrogen (BUN) ≤2X ULN.
- FFPE tumor tissue should be available from the current relapse, if obtainable, otherwise the most recent archival tumor tissue. Note: Patients treated with a PARP inhibitor must have a new biopsy unless there is an archival biopsy that was done after the PARP inhibitor treatment was discontinued.
- Negative serum pregnancy test in women of childbearing potential (WOCBP). WOCBP is defined as premenopausal women or less than 12 months of amenorrhea post-menopause, and women who have not undergone surgical sterilization or hysterectomy or bilateral salpingo-oophorectomy.
- Sexually active females of childbearing potential must use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception) for the study duration and at least six months afterwards.
Exclusion
- Patients who have platinum-refractory disease, defined as progression during the last platinum-based chemotherapy.
- Concurrent chemotherapy, antibody therapies radiotherapy,hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period.
- Other malignancy with exception of any stage I and II cancer that is deemed cured by the Investigator.
- Any active infection requiring parenteral or oral antibiotic treatment.
- Known HIV positivity.
- Known active hepatitis B or C.
- Clinically significant cardiovascular disease:
- Stroke within ≤ 12 months prior to day 1
- Transient ischemic attach (TIA) within ≤ 12 months prior to day 1
- Myocardial infarction within ≤ 12 months prior to day 1
- Unstable angina
- New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF)
- Uncontrolled cardiac arrhythmia requiring medication
- Other medications or conditions that in the Investigator's opinion would contraindicate study participation for 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, diarrhea, 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, psychological, housed in an institution e.g., prison because of a court agreement or administrative order).
- Patients, who are close colleagues, associates, or family members of, or in any way dependent on the sponsor or the investigator.
- Ascites requiring drainage \>500cc in the 2 weeks prior to enrolment.
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03878849
Start Date
April 15 2019
End Date
September 1 2027
Last Update
August 28 2025
Active Locations (2)
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1
OU Health Stephenson Cancer
Oklahoma City, Oklahoma, United States, 73104
2
Swedish Center for Research and Innovation
Seattle, Washington, United States, 98122