Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer
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.
|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|
- 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 ]
- 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)
|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)|
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
MGCD516 capsules will be taken with water.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02219711
|Contact: Mirati Therapeutics Study Locator Services||1-844-356-0895 (toll-free)||firstname.lastname@example.org|
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