MedPath

Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer

Phase 1
Completed
Conditions
Advanced Cancer
Interventions
Registration Number
NCT02219711
Lead Sponsor
Mirati Therapeutics Inc.
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
193
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
MGCD516MGCD516MGCD516 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
Primary Outcome Measures
NameTimeMethod
Peak Plasma Concentration (Cmax) of MGCD516Up to 72 hours
Type of dose limiting adverse eventUp to 3 weeks on treatment
Area under the plasma concentration versus time curve (AUC) of MGCD516Up to 72 hours
Secondary Outcome Measures
NameTimeMethod
Kind of metabolites of MGCD516 in blood plasmaUp to 9 weeks on treatment
Concentration of selected marker proteins in blood plasmaUp to 9 weeks on treatment

Proteins include VEGF A, soluble VEGF-R2 and soluble MET

Percent of patients having objective disease response to treatmentUp to 1 year on treatment

Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Trial Locations

Locations (43)

University of Alabama

🇺🇸

Birmingham, Alabama, United States

University of California, San Diego

🇺🇸

San Diego, California, United States

University of California, San Francisco

🇺🇸

San Francisco, California, United States

Sarcoma Oncology Research Center

🇺🇸

Santa Monica, California, United States

Innovative Clinical Research Institute

🇺🇸

Whittier, California, United States

Rocky Mountain Cancer Center

🇺🇸

Denver, Colorado, United States

Holy Cross Michael & Dianne Bienes Comprehensive Cancer Center

🇺🇸

Fort Lauderdale, Florida, United States

Florida Cancer Affiliates

🇺🇸

Ocala, Florida, United States

Florida Cancer Specialists

🇺🇸

Sarasota, Florida, United States

Northwestern University

🇺🇸

Chicago, Illinois, United States

Scroll for more (33 remaining)
University of Alabama
🇺🇸Birmingham, Alabama, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.