Drug- Drug Interaction Study of JI-101 & Everolimus in Advanced Solid Tumors, Expansion Pharmacodynamic Study of JI-101 in Advanced Low Grade Endocrine Tumors, Ovarian Cancers or K-RAS Mutant Colon Cancers
This is a multi-center, non-randomized, open-label study to evaluate the safety and efficacy
of RAD001 and JI-101 in patients with solid tumors.
Patients will complete all Screening evaluations within 21 days of Study Cycle 1Day 1. All
patients will provide written Informed consent and HIPAA authorization before any procedures
or assessments are initiated for the purposes of the protocol.
For the Drug Interaction Study, Everolimus will be administered to eligible patients at
Cycle 1 Day 1 and blood will be drawn for pharmacokinetic analyses prior to dosing and at
0.5, 1, 2, 4, 6, 8, 10, and 24 hours after dosing. On Day 8, Everolimus and JI-101 will be
administered and blood will be drawn for pharmacokinetic analyses prior to dosing and at
0.5, 1, 2, 4, 6, 8, 10, and 24 hours after dosing. On Day 15, JI-101 will be administered
and blood will be drawn for pharmacokinetic analyses prior to dosing and at 0.5, 1, 2, 4, 6,
8, 10, and 24 hours after dosing. Patients will continue to receive JI-101(200 mg BID) for
28 day treatment cycles. Patients in the Drug Interaction Study will also receive CT scans
prior to screening and every 2 treatment cycles.
For the Pharmacodynamic Study, JI-101 will be dispensed to eligible patients at Cycle 1 Day
1. JI-101 will be administered (200 mg BID) for 28 day treatment cycles. PET and CT scans
will be performed prior to commencing treatment if it is standard of care. A CT scan will be
performed otherwise. Patients will return to the study site every 2 cycles to complete
safety assessments with radiologic tumor assessments (CT and/or PET). Adverse events will
be monitored following the first administration of investigational product for the duration
of the patient's participation in this study. Archival tissue will be collected for
detection of mutations in relevant pathways and development of assays to study modulation of
pathways that are targeted by JI-101.
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome for Drug Interaction Study
The primary study objective for the Drug Interaction Study is to determine the pharmacokinetic interactions between RAD001 and JI-101
Sunil Sharma, MD
Huntsman Cancer Institute
United States: Food and Drug Administration
|Huntsman Cancer Institute||Salt Lake City, Utah 84112|