Study of JI-101 in Patients With Advanced Low Grade Endocrine Tumors, Ovarian Cancers or K-RAS Mutant Colon Cancers
Status:
Terminated
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
The study consists of two parts: Drug Interaction (Pharmacokinetic) Phase and Pharmacodynamic
Phase
The primary study objective for the Drug Interaction Study is to determine the
pharmacokinetic interactions between RAD001 and JI-101.
The primary study objective for the Pharmacodynamic Study is progression-free survival at 2
moths, evaluated separately in each of the three cohorts.
These will include a determination of tumor response using Response Evaluation Criteria in
Solid Tumors (RECIST) Criteria and an assessment of ephrinB4 expression in blood samples.
Secondary objectives are to determine safety and tolerability of JI-101. The investigational
products are everolimus (42-O-(2-hydroxyethyl) rapamycin) and JI-101
(1-[1-(2-amino-pyridin-4-ylmethyl)-1H-indol-4-yl]-3-(5-bromo-2 methoxy-phenyl)-urea)
Eligible patients meeting all study entry criteria will be enrolled in the study. For the
Drug Interaction study, patients with solid tumors will receive a single dose (10 mg) of
Everolimus by mouth on Day 1 and Day 8 and JI-101 capsules (200 mg) by mouth on Day 8 and Day
15. For the Pharmacodynamic Study, all patients will receive JI-101 capsules by mouth (200 mg
BID) for 28 day treatment cycles.