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

March 10, 2023 updated by: Allarity Therapeutics

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®

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
      • London, United Kingdom, SE1 9TR
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust
        • Contact:
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Completed
        • Dana-Farber Cancer Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OU Health Stephenson Cancer
        • Principal Investigator:
          • Kathleen Moore, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Center for Research and Innovation
        • Contact:
        • Principal Investigator:
          • Fernanda Baptista Musa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2X-121
Oral administration of 2X-121 once daily as 600 mg hard gelatin capsules in a 28 days cycle.
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.
Other Names:
  • E7449, MGI25036
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical benefit rate (CBR)
Time Frame: evaluated after up to approximately 2 years
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
Progression free survival
Time Frame: evaluated after up to approximately 2 years
from baseline to progression or death
evaluated after up to approximately 2 years
Duration of response
Time Frame: evaluated after up to approximately 2 years
from first response to progression
evaluated after up to approximately 2 years
Overall survival
Time Frame: evaluated after up to approximately 2 years
from baseline until death
evaluated after up to approximately 2 years
Quality of Life measurement
Time Frame: at baseline and start of each cycle, up to approximately 2 years
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
Correlation between 2X-121 DRP® and clinical outcome
Time Frame: evaluated after up to approximately 2 years
comparing the DRP levels in the different response groups
evaluated after up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allarity Therapeutics

Collaborators

Amarex Clinical Research
Alcedis GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

March 8, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (PARPi) 2X-1002
  • 2020-000539-31 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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