Spots Global Cancer Trial Database for Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas
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Trial Identification
Brief Title: Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas
Official Title: A Phase 2 Multi-center Pharmacodynamics Study of TVB-2640 in KRAS Mutant Non-small Cell Lung Carcinomas
Study ID: NCT03808558
Conditions
Interventions
Study Description
Brief Summary: This is a prospective one-arm, two-stage phase 2 trial of TVB-2640 in KRAS mutant NSCLC patients. 13 patients will be treated with a minimum of 1 cycle of TVB-2640 therapy over 8 weeks.
Detailed Description: Patients with stable disease or partial/complete remissions will continue therapy. The endpoints are response rate-RR, disease control rate-DCR, PFS-progression-free survival, CTCAEv5.0 toxicities, plasma lipid levels, collection of sebaceous secretion via Sebutape, and 11C-acetate PET tumor imaging. In the first stage, 13 patients will be enrolled. If fewer than 2 patients achieve response, the study will be stopped. If 2 or more patients have a radiographic response, an additional 21 patients will be enrolled , for a total accrual of 34 patients.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Cincinnati, Cincinnati, Ohio, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Contact Details
Name: David Gerber, MD
Affiliation: Professor
Role: PRINCIPAL_INVESTIGATOR
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