Manavata Clinical Research Institute | HCG Manavata Cancer Centr
Status and phase
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Study type
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About
The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.
Full description
Adaptive sample size re-estimation will be performed at interim analysis. The sample size could be increased from approximately 250 to 400 depending on the results of interim analysis.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
At least 18 years of age (participants as young as 12 years of age will be allowed if permitted by local regulatory authorities).
Histologically or cytologically confirmed, unresectable, locally advanced and/or metastatic MTC and no prior history of treatment with kinase inhibitors for advanced/metastatic disease.
Radiographic progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at screening compared with a previous image taken within the prior 14 months as assessed by the BICR. Participants with measurable or non-measurable but evaluable disease are eligible; however, participants with non-measurable disease may not have disease limited to bone sites only.
A defined/acceptable RET gene alteration identified in a tumor, germline deoxyribonucleic acid (DNA) or blood sample.
Eastern Cooperative Oncology Group performance status score of 0 to 2.
Adequate hematologic, hepatic, and renal function and electrolytes.
Men and women of childbearing potential must agree to use a highly effective contraceptive method during treatment with study drug and for 4 months following the last dose of study drug.
Ability to swallow capsules.
Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
291 participants in 2 patient groups
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Central trial contact
There will be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Data sourced from clinicaltrials.gov
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