Spots Global Cancer Trial Database for A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm
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Trial Identification
Brief Title: A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm
Official Title: A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm
Study ID: NCT01905228
Interventions
Study Description
Brief Summary: This is an open-label, multi-center, sequential groups, dose-escalation study of CBL0137 administered intravenously in participants with metastatic or unresectable advanced solid malignancies.
Detailed Description: The primary objective of the study is to determine the maximally tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of CBL0137. The secondary objectives are to describe the dose-limiting toxicity (DLT) and adverse event profile of CBL0137, to describe the pharmacokinetic profile of CBL0137, to document any objective responses to CBL0137. This is a study of CBL0137 with a standard "3+3" design. Escalation will proceed to the MTD based on DLT in the 1st cycle in 1 of 6 participants in a cohort.
Eligibility
Minimum Age: 15 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Roswell Park Cancer Institute, Buffalo, New York, United States
University Hospital of Cleveland, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
CTRC at The University of Texas Healh Science Center at San Antonio, San Antonio, Texas, United States
Contact Details
Name: John Sarantopoulos, MD
Affiliation: The University of Texas Health Science Center at San Antonio
Role: PRINCIPAL_INVESTIGATOR
Name: Renuka Iyer, MD
Affiliation: Roswell Park Cancer Institue
Role: PRINCIPAL_INVESTIGATOR
Name: Afshin Dowlati, MD
Affiliation: University Hospital of Cleveland
Role: PRINCIPAL_INVESTIGATOR
Name: Manmeet Ahluwalia, MD
Affiliation: The Cleveland Clinic
Role: PRINCIPAL_INVESTIGATOR
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