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

Advanced Ovarian Cancer Clinical Trial

— PREDICT 2X-121  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03878849
• Other study ID #: (PARPi) 2X-1002
• Secondary ID: 2020-000539-31
• Status: Recruiting
• Phase: Phase 2
• Start date: April 15, 2019
• Est. completion date: March 2024

Study information

• Verified date: March 2023
• Source: Allarity Therapeutics
• Contact: USA: Kathleen Moore
• Phone: +1 405-271-8707
• Email: KathleenMoore[@]ouhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Ovarian Cancer
• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms

Intervention

Drug:
• 2X-121
Every patient will receive daily oral administrations of 3 x 200 mg 2X-121 hard gelatin capsules in a 28-day cycle.

Device:
• 2X-121 DRP®
A DRP is an assay that based on samples from a tumor can predict whether the tumor will respond to a specific drug or not.

Locations

Country	Name	City	State
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	OU Health Stephenson Cancer	Oklahoma City	Oklahoma
United States	Swedish Center for Research and Innovation	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Allarity Therapeutics	Alcedis GmbH, Amarex Clinical Research

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

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