|Secondary Protocol No.
||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
||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
||21 days on Minnelide, followed by 7 day break.
||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
||Masonic Cancer Center