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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 : October 27, 2020
Sponsor:
Collaborators:
Alcedis GmbH
Amarex Clinical Research
Information provided by (Responsible Party):
Allarity Therapeutics

Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE March 18, 2019
Last Update Posted Date October 27, 2020
Actual Study Start Date  ICMJE April 15, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
  • 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
  • Progression free survival [ Time Frame: evaluated after up to approximately 2 years ]
    from baseline to progression or death
  • Duration of response [ Time Frame: evaluated after up to approximately 2 years ]
    from first response to progression
  • Overall survival [ Time Frame: evaluated after up to approximately 2 years ]
    from baseline until death
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of 2X-121 in Patients With Advanced Ovarian Cancer Selected by the 2X-121 DRP®
Official Title  ICMJE 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®
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Ovarian Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: 2X-121
Oral administration of 2X-121 once daily as 600 mg hard gelatin capsules in a 28 days cycle.
Interventions:
  • Drug: 2X-121
  • Device: 2X-121 DRP®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: USA: Christin Whalen, RN +617-582-7738 christin_whalen@DFCI.HARVARD.EDU
Contact: Europe: Sehouli, Prof. Dr.Med
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03878849
Other Study ID Numbers  ICMJE (PARPi) 2X-1002
2018-003341-41 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allarity Therapeutics
Study Sponsor  ICMJE Allarity Therapeutics
Collaborators  ICMJE
  • Alcedis GmbH
  • Amarex Clinical Research
Investigators  ICMJE Not Provided
PRS Account Allarity Therapeutics
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP