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

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ClinicalTrials.gov Identifier: NCT03878849
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : March 13, 2023
Sponsor:
Collaborators:
Alcedis GmbH
Amarex Clinical Research
Information provided by (Responsible Party):
Allarity Therapeutics

Study Description
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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
Advanced Ovarian Cancer Drug: 2X-121 Device: 2X-121 DRP® Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 15, 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Progression free survival [ Time Frame: evaluated after up to approximately 2 years ]
    from baseline to progression or death

  3. Duration of response [ Time Frame: evaluated after up to approximately 2 years ]
    from first response to progression

  4. Overall survival [ Time Frame: evaluated after up to approximately 2 years ]
    from baseline until death

  5. 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

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878849


Contacts
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Contact: USA: Kathleen Moore +1 405-271-8707 KathleenMoore@ouhealth.com
Contact: Europe: Rebecca Kristeleit Rebecca.Kristeleit@gstt.nhs.uk

Locations
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United States, Massachusetts
Dana-Farber Cancer Institute Completed
Boston, Massachusetts, United States, 02215
United States, Oklahoma
OU Health Stephenson Cancer Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Christine Pappaterra    405-271-8707    Christine-Pappaterra@ouhsc.edu   
Principal Investigator: Kathleen Moore, MD         
United States, Washington
Swedish Center for Research and Innovation Recruiting
Seattle, Washington, United States, 98122
Contact: Karina Sills    206-386-2227    karina.sills@swedish.org   
Principal Investigator: Fernanda Baptista Musa, MD         
United Kingdom
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom, G12 0YN
Contact: Rosalind Glasspool, MD       ros.glasspool@ggc.scot.nhs.uk   
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 9TR
Contact: Ana Montes, MD    44 (0)20718887539    Ana.Montes@gstt.nhs.uk   
Principal Investigator: Rebecca Kristeleit         
Sponsors and Collaborators
Allarity Therapeutics
Alcedis GmbH
Amarex Clinical Research
More Information
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Responsible Party: Allarity Therapeutics
ClinicalTrials.gov Identifier: NCT03878849    
Other Study ID Numbers: (PARPi) 2X-1002
2020-000539-31 ( EudraCT Number )
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type