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

Sponsor
Allarity Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03878849
Collaborator
Alcedis GmbH (Industry), Amarex Clinical Research (Other)
60
Enrollment
3
Locations
1
Arm
46.5
Anticipated Duration (Months)
20
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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®
Actual Study Start Date :
Apr 15, 2019
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) [evaluated after up to approximately 2 years]

      defined as complete response (CR) or partial response (PR) using the RECIST criteria version 1.1

    Secondary Outcome Measures

    1. Clinical benefit rate (CBR) [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

    2. Progression free survival [evaluated after up to approximately 2 years]

      from baseline to progression or death

    3. Duration of response [evaluated after up to approximately 2 years]

      from first response to progression

    4. Overall survival [evaluated after up to approximately 2 years]

      from baseline until death

    5. Quality of Life measurement [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

    6. Correlation between 2X-121 DRP® and clinical outcome [evaluated after up to approximately 2 years]

      comparing the DRP levels in the different response groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    2 Beatson West of Scotland Cancer Centre Glasgow United Kingdom G12 0YN
    3 Guy's and St Thomas' NHS Foundation Trust London United Kingdom SE1 9TR

    Sponsors and Collaborators

    • Allarity Therapeutics
    • Alcedis GmbH
    • Amarex Clinical Research

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allarity Therapeutics
    ClinicalTrials.gov Identifier:
    NCT03878849
    Other Study ID Numbers:
    • (PARPi) 2X-1002
    • 2020-000539-31
    First Posted:
    Mar 18, 2019
    Last Update Posted:
    May 25, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial

    Study Results

    No Results Posted as of May 25, 2022