Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer
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| ClinicalTrials.gov Identifier: NCT02219711 |
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Recruitment Status :
Completed
First Posted : August 19, 2014
Last Update Posted : March 6, 2023
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Cancer | Drug: MGCD516 | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 193 participants |
| Allocation: | N/A |
| 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 |
| Study Start Date : | August 2014 |
| Actual Primary Completion Date : | April 27, 2022 |
| Actual Study Completion Date : | April 27, 2022 |
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: MGCD516
MGCD516 is a small molecule inhibitor of several closely related receptor tyrosine kinases. MGCD516 capsules will be taken with water.
Other Name: Sitravatinib |
- 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)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
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| Study Director: | Richard Chao, MD | Mirati Therapeutics Inc. |
| Responsible Party: | Mirati Therapeutics Inc. |
| ClinicalTrials.gov Identifier: | NCT02219711 |
| Other Study ID Numbers: |
516-001 |
| First Posted: | August 19, 2014 Key Record Dates |
| Last Update Posted: | March 6, 2023 |
| Last Verified: | March 2023 |
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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 Sitravatinib |
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Neoplasms |