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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MGCD516 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGCD516 | Drug | MGCD516 is a small molecule inhibitor of several closely related receptor tyrosine kinases. MGCD516 capsules will be taken with water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Type of dose limiting adverse event | Up to 3 weeks on treatment | |
| Area under the plasma concentration versus time curve (AUC) of MGCD516 | Up to 72 hours | |
| Peak Plasma Concentration (Cmax) of MGCD516 | Up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Kind of metabolites of MGCD516 in blood plasma | Up to 9 weeks on treatment | |
| Concentration of selected marker proteins in blood plasma | Proteins include VEGF A, soluble VEGF-R2 and soluble MET |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Chao, MD | Mirati Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| University of California, San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39513224 | Derived | Bazhenova L, Kim DW, Cho BC, Goel S, Heist R, Werner TL, Eaton KD, Wang JS, Pant S, Adkins DR, Blakely CM, Yan X, Neuteboom S, Christensen JG, Chao R, Bauer T. Sitravatinib in patients with solid tumors selected by molecular alterations: results from a Phase Ib study. Future Oncol. 2024 Dec;20(39):3213-3227. doi: 10.1080/14796694.2024.2418285. Epub 2024 Nov 8. | |
| 39168901 |
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| Up to 9 weeks on treatment |
| Percent of patients having objective disease response to treatment | Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Up to 1 year on treatment |
| San Diego |
| California |
| 92093 |
| United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Sarcoma Oncology Research Center | Santa Monica | California | 90403 | United States |
| Innovative Clinical Research Institute | Whittier | California | 90602 | United States |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States |
| Holy Cross Michael & Dianne Bienes Comprehensive Cancer Center | Fort Lauderdale | Florida | 33308 | United States |
| Florida Cancer Affiliates | Ocala | Florida | 34471 | United States |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Maryland Oncology Hematology, | Rockville | Maryland | 20850 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Washington University Center for Advanced Medicine | St Louis | Missouri | 63110 | United States |
| CHI Health St Francis, Saint Francis Cancer Treatment Center | Grand Island | Nebraska | 68803 | United States |
| Oncology Hematology West PC, Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | United States |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico | 87102 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45242 | United States |
| Guthrie Clinical Research | Sayre | Pennsylvania | 18840 | United States |
| St. Francis Cancer Center | Greenville | South Carolina | 29607 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Texas Oncology-Austin Midtown | Austin | Texas | 78705 | United States |
| Mary Crowley Cancer Research Center | Dallas | Texas | 75251 | United States |
| University of Texas, MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Texas Oncology-Tyler | Tyler | Texas | 75702 | United States |
| The Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc., Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Northwest Cancer Specialists, P.C. | Vancouver | Washington | 98684 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Chungbuk National University Hospital | Cheongju-si | South Korea |
| Keimyung University Dongsan Hospital | Daegu | South Korea |
| National Cancer Center | Goyang-si | South Korea |
| Korea Veterans Health Service | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea |
| Pant S, Cho BC, Kyriakopoulos CE, Spira A, Tannir N, Werner TL, Yan X, Neuteboom S, Chao R, Goel S. Targeting multiple receptor tyrosine kinases with sitravatinib: A Phase 1b study in advanced renal cell carcinoma and castrate-resistant prostate cancer. Invest New Drugs. 2024 Oct;42(5):547-558. doi: 10.1007/s10637-024-01465-9. Epub 2024 Aug 21. |
| 35767205 | Derived | Bauer T, Cho BC, Heist R, Bazhenova L, Werner T, Goel S, Kim DW, Adkins D, Carvajal RD, Alva A, Eaton K, Wang J, Liu Y, Yan X, Christensen J, Neuteboom S, Chao R, Pant S. First-in-human phase 1/1b study to evaluate sitravatinib in patients with advanced solid tumors. Invest New Drugs. 2022 Oct;40(5):990-1000. doi: 10.1007/s10637-022-01274-y. Epub 2022 Jun 29. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D006258 | Head and Neck Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |
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| ID | Term |
|---|---|
| C000611865 | sitravatinib |
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