Spots Global Cancer Trial Database for Study of Minnelide™ in Patients With Advanced GI Tumors
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Trial Identification
Brief Title: Study of Minnelide™ in Patients With Advanced GI Tumors
Official Title: A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Given Daily for 21 Days Followed by 7 Days Off Schedule in Patients With Advanced GI Tumors.
Study ID: NCT01927965
Conditions
Interventions
Study Description
Brief Summary: The primary objective of this study is to determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of Minnelide™ and to establish the dose of Minnelide™ recommended for future phase 2 protocol
Detailed Description: This is a Phase 1, open label, multicenter, dose-escalation study of safety, pharmacokinetics, and pharmacodynamics of Minnelide™ Minnelide™ will be given as a single agent intravenously as a 30-minute infusion daily x 21 days followed by a 7-day rest period. One cycle will equal 28 days. Dose escalation will follow a modified Fibonacci design.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Virginia G. Piper Cancer Center at Scottsdale Healthcare, Scottsdale, Arizona, United States
University of Minnesota Masonic Cancer Clinic, Minneapolis, Minnesota, United States
Contact Details
Name: Mohana Velagapudi, MD
Affiliation: Minneamrita Therapeutics LLC
Role: STUDY_DIRECTOR
Name: Linda Vocila, BSN
Affiliation: Translational Drug Development
Role: STUDY_DIRECTOR
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