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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.

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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

FieldValue
Enrollment Target 174 participants
Start Date 2014-03-01
Est. Completion 2024-01-04
Phase Phase 1

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.