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NCT02073994 · ClinicalTrials.gov registry record · Phase 1
Study of Orally Administered AG-120 in Subjects With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation
A Phase 1 study, sponsored by Institut de Recherches Internationales Servier.
- Completed
- Registry status
- Phase 1
- Development phase
- 174
- Enrollment target
NCT02073994 is a Phase 1 study that has completed, run by Institut de Recherches Internationales Servier. The registered enrollment target is 174 participants.
The verdict
NCT02073994, a Phase 1 study, has completed, sponsored by Institut de Recherches Internationales Servier.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 174 participants
- Enrollment target
Study Summary
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced solid tumors, including glioma, that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four arms of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Anticipated time on study treatment is until disease progression, unacceptable toxicity occurs or at Investigator discretion.
Interventions
- DRUG AG-120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2014-03-01 |
| Est. Completion | 2024-01-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02073994
The ClinicalTrials.gov registry entry for NCT02073994 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Institut de Recherches Internationales Servier, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AG-120 is the first listed.
NCT02073994 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02073994 about?
NCT02073994 is a clinical study titled "Study of Orally Administered AG-120 in Subjects With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation". The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced solid tumors, including glioma, that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients w...
What is the current status of trial NCT02073994?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 174 participants. The study started on 2014-03-01. Estimated completion is 2024-01-04.
What interventions are being tested in trial NCT02073994?
The interventions under investigation include: AG-120 (DRUG).
Who is sponsoring clinical trial NCT02073994?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.
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