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Protocol No. 2013LS031 Principal Investigator Greeno, Edward
Phase Phase I
Age Group Adult Scope National
Secondary Protocol No. Minnelide 001
Title A Phase I, Multicenter, 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
Objective To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of Minnelide™. To establish the dose of Minnelide™ recommended for future phase 2 protocol
Treatment 21 days on Minnelide, followed by 7 day break.
Key Eligibility Histologically or cystologically confirmed GI carcinoma, which has progressed on standard therapies (surgery, radiotherapy, endocrine therapy, chemotherapy), for which effective therapy is not available or for a patients who are not a candidate or intolerance of such therapies. Have one or more metastatic tumors measurable on CT scan or locally advanced measurable disease on CT scan that has clearly progressed after prior treatment per RECIST criteria, male and females at least 18 years of age, estimated life expectancy of at least 3 months
Applicable Disease Sites Colon
Pancreas
Small Intestine
Stomach
Drugs Involved Minnelide
Status Open
Participating Institutions Masonic Cancer Center
Treatment Type Treatment
Contact Carrie McCann Phone:612-626-2569
Email:mcca0313@umn.edu
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