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NCT00842335 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2, Open-Label, Dose-Escalation Study of JI-101, in Patients With Advanced Solid Tumors
A Phase 1 study of Advanced Solid Tumors, sponsored by Jubilant Innovation.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT00842335: Completed Phase 1 study of Advanced Solid Tumors, sponsored by Jubilant Innovation.
NCT00842335 is a Phase 1 study of Advanced Solid Tumors that has completed, run by Jubilant Innovation. The registered enrollment target is 18 participants, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00842335, a Phase 1 study of Advanced Solid Tumors, has completed, sponsored by Jubilant Innovation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study, the first clinical trial of JI-101, is to determine the maximum tolerated dose of JI-101 when given orally to patients with solid tumors. Safety, tolerability, pharmacokinetics, pharmacodynamics, and the effects of the drug on tumor metabolism will also be studied. JI-101 is an inhibitor of new blood vessel growth that may provide benefit to patients with solid tumors that have failed standard therapeutic regimens.
Primary Outcome
The primary objective of this study was to determine the maximum tolerated dose (MTD) of JI-101 when administered orally in patients with advanced solid tumors. The MTD was established based on safety data from Cycle 1. Patients who completed 21 days of treatment in Cycle 1 were considered to have completed the study for the determination of MTD. Patients were eligible to continue treatment with JI-101 until they experienced disease progression or unacceptable treatment-related toxicity. Unacc
Conditions Studied
Interventions
- DRUG JI-101
Study Locations (1)
Arizona
- Premiere Oncology of Arizona - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2009-02 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
What the finished NCT00842335 record still lists
NCT00842335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which JI-101 is the first listed.
NCT00842335 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT00842335 about?
NCT00842335 is a clinical study titled "A Phase 1/2, Open-Label, Dose-Escalation Study of JI-101, in Patients With Advanced Solid Tumors". The purpose of this study, the first clinical trial of JI-101, is to determine the maximum tolerated dose of JI-101 when given orally to patients with solid tumors. Safety, tolerability, pharmacokinetics, pharmacodynamics, and the effects of the drug on tumor metabolism will also be studied. JI-101 ...
What is the current status of trial NCT00842335?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2009-02. Estimated completion is 2012-01.
What conditions does trial NCT00842335 study?
This clinical trial studies the following conditions: Advanced Solid Tumors.
What interventions are being tested in trial NCT00842335?
The interventions under investigation include: JI-101 (DRUG).
Who is sponsoring clinical trial NCT00842335?
This trial is sponsored by Jubilant Innovation, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00842335 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00842335's enrollment target sits among peer trials
18 128th of 144 higher than 15 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors 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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