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

Allarity Therapeutics

Status and phase

Active, not recruiting

Phase 2

Conditions

Advanced Ovarian Cancer

Treatments

Drug: 2X-121

Device: 2X-121 DRP®

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03878849

(PARPi) 2X-1002

2020-000539-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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