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Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study

Sponsor
Mirati Therapeutics Inc. (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04887870
Collaborator
(none)
200
Enrollment
13
Locations
1
Arm
31.1
Anticipated Duration (Months)
15.4
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Study of Sitravatinib Alone or in Combination with Other Anticancer Therapies in Advanced or Metastatic Malignancies

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs including the TAM family (Tyro3/Axl/MERTK), VEGFR2, KIT, and MET.

The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-label Rollover Study of Sitravatinib Alone or in Combination With Other Anticancer Therapies in Patients With Advanced or Metastatic Solid Malignancies
Actual Study Start Date :
Jun 30, 2021
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase 2/3: Open label extension of parent study

The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.

Drug: Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
Other Names:
  • MGCD516

    • Drug: Nivolumab
    Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
    Other Names:
  • OPDIVO

    • Drug: Pembrolizumab
    Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody
    Other Names:
  • KEYTRUDA

    • Drug: Enfortumab Vedotin-Ejfv
    Enfortumab is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a monoclonal antibody conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E (MMAE)
    Other Names:
  • PADCEV

    • Drug: Ipilimumab
    Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
    Other Names:
  • YERVOY

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Frequency of subjects experiencing treatment-related AEs. [24 Months]

      Frequency of subjects experiencing treatment-related AEs.

    Secondary Outcome Measures

    1. Time to clinical or radiographic progression on study. [24 Months]

      Time to clinical or radiographic progression on study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Currently receiving sitravatinib single- agent or in combination with other therapeutic agent(s) in another Mirati- sponsored protocol

    • Currently tolerating the treatment regimen in the parent protocol

    • Experiencing clinical benefit with or without prior radiographic progression from the treatment regimen in the parent protocol in the opinion of the investigator and the investigator determines that continuing treatment is in the patient's best interest

    Exclusion Criteria:

    • Known or suspected presence of other cancer

    • Other life- threatening illness or organ system dysfunction compromising safety evaluation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beverly Hills Cancer Center Beverly Hills California United States 90211
    2 Rocky Mountain Cancer Centers Aurora Colorado United States 90012
    3 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    4 Karmanos Cancer Institute Detroit Michigan United States 48201
    5 University of Minnesota Health Clinics and Surgery Center Minneapolis Minnesota United States 55455
    6 GU Research Network/Urology Cancer Center Omaha Nebraska United States 68130
    7 New York Oncology Hematology, P.C. Clifton Park New York United States 12065
    8 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    9 The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic Columbus Ohio United States 43210
    10 Texas Oncology - Denison Cancer Center Denison Texas United States 75020
    11 UT MD Anderson Cancer Center Houston Texas United States 77030
    12 NEXT Oncology San Antonio Texas United States 78229
    13 NEXT Virginia Fairfax Virginia United States 22031

    Sponsors and Collaborators

    • Mirati Therapeutics Inc.

    Investigators

    • Study Director: Ronald Shazer, MD, Mirati Therapeutics Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mirati Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT04887870
    Other Study ID Numbers:
    • 516-014
    First Posted:
    May 14, 2021
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Pembrolizumab
    Nivolumab
    Ipilimumab

    Study Results

    No Results Posted as of Aug 25, 2022