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NCT01149434 · ClinicalTrials.gov registry record · Phase 1
Study of JI-101 in Patients With Advanced Low Grade Endocrine Tumors, Ovarian Cancers or K-RAS Mutant Colon Cancers
A Phase 1 study, sponsored by University of Utah.
- Terminated
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01149434: Clinical Trial Phase 1 study, sponsored by University of Utah.
NCT01149434 is a Phase 1 study that was terminated before completion, run by University of Utah. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01149434, a Phase 1 study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study 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.
Primary Outcome
Determine the mean percent change that JI-101 has on the peak concentration as determined by calculating the AUC (0-inf) of RAD001 in the presence and absence of JI-101
Interventions
- DRUG Everolimus
- DRUG JI-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
Why NCT01149434 stopped before completion
NCT01149434 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT01149434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01149434 about?
NCT01149434 is a clinical study titled "Study of JI-101 in Patients With Advanced Low Grade Endocrine Tumors, Ovarian Cancers or K-RAS Mutant Colon Cancers". 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 pr...
What is the current status of trial NCT01149434?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2010-09. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01149434?
The interventions under investigation include: Everolimus (DRUG), JI-101 (DRUG).
Who is sponsoring clinical trial NCT01149434?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01149434's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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