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Trial record 1 of 4 for:    mgcd516
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Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer

This study is currently recruiting participants.
Verified July 2017 by Mirati Therapeutics Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02219711
First Posted: August 19, 2014
Last Update Posted: July 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mirati Therapeutics Inc.
  Purpose

MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR, DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism, pharmacodynamic and clinical activity profiles.

During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed; during the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations.

Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor type, including but not limited to, non small cell lung cancer and head and neck cancer positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3 gene loci, or having loss of function mutations in the CBL gene. In addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled.


Condition Intervention Phase
Advanced Cancer Drug: MGCD516 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/1b Study of MGCD516 in Patients With Advanced Solid Tumor Malignancies

Resource links provided by NLM:


Further study details as provided by Mirati Therapeutics Inc.:

Primary Outcome Measures:
  • Type of dose limiting adverse event [ Time Frame: Up to 3 weeks on treatment ]
  • Area under the plasma concentration versus time curve (AUC) of MGCD516 [ Time Frame: Up to 72 hours ]
  • Peak Plasma Concentration (Cmax) of MGCD516 [ Time Frame: Up to 72 hours ]

Secondary Outcome Measures:
  • Kind of metabolites of MGCD516 in blood plasma [ Time Frame: Up to 9 weeks on treatment ]
  • Concentration of selected marker proteins in blood plasma [ Time Frame: Up to 9 weeks on treatment ]
    Proteins include VEGF A, soluble VEGF-R2 and soluble MET

  • Percent of patients having objective disease response to treatment [ Time Frame: Up to 1 year on treatment ]
    Response Evaluation Criteria in Solid Tumors (RECIST 1.1)


Estimated Enrollment: 260
Study Start Date: August 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MGCD516
MGCD516 oral capsule, administered in escalating doses in Phase 1, beginning with daily dosing and exploring other regimens as necessary, in 21 or 28 days cycles
Drug: MGCD516
MGCD516 capsules will be taken with water.

Detailed Description:

During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed.

During the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations. Patients anticipated to be enrolled in Phase 1b will be selected based upon the following cancer diagnosis:

Non-small cell lung cancer with genetic alterations in MET, AXL, RET, TRK, DDR2, KDR, PDGFRA, KIT or CBL.

Head and neck squamous cell carcinoma with genetic alterations in MET.

Clear cell renal cell carcinoma refractory to angiogenesis inhibitors.

Metastatic prostate cancer with bone metastases.

Other cancer diagnosis having a selected genetic alteration in MGCD516 target RTKs.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic or unresectable solid tumor malignancy
  • Standard treatment is not available
  • Adequate bone marrow and organ function

Exclusion Criteria:

  • History of a significant cardiovascular illness
  • Prolonged corrected QT (QTc) interval
  • Left ventricular ejection fraction < 40%
  • Symptomatic or uncontrolled brain metastases
  • Other active cancer
  Contacts and Locations
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): NCT02219711


Contacts
Contact: Mirati Therapeutics Study Locator Services 1-844-356-0895 (toll-free) miratistudylocator@emergingmed.com

  Show 26 Study Locations
Sponsors and Collaborators
Mirati Therapeutics Inc.
  More Information

Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02219711     History of Changes
Other Study ID Numbers: 516-001
First Submitted: August 14, 2014
First Posted: August 19, 2014
Last Update Posted: July 18, 2017
Last Verified: July 2017

Keywords provided by Mirati Therapeutics Inc.:
MGCD516
MET
AXL
RET
TRK
NTRK
DDR2
KDR
VEGFR
PDGFRA
KIT
Tyrosine kinase inhibitor
NSCLC
Non-small cell lung cancer
Head and neck cancer
Renal cell carcinoma
Prostate cancer
Phase 1
CBL

Additional relevant MeSH terms:
Neoplasms