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NCT00867113 · ClinicalTrials.gov registry record · Phase 2

Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)

A Phase 2 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
91
Enrollment target

NCT00867113: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.

NCT00867113 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 91 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00867113, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
91 participants
Enrollment target

Study Summary

This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The purpose of this trial is to evaluate the use of long term adjuvant imatinib mesylate in patients at significant risk for recurrence following complete resection of primary GIST.

Primary Outcome

Recurrence-free survival assessment is based on the radiologic evidence and is defined as the time from the date of first dose of imatinib to the date of the first documented disease recurrence or death due to any cause (event).

Interventions

  • DRUG imatinib mesylate

Trial Details

FieldValue
Enrollment Target 91 participants
Start Date 2009-07-22
Est. Completion 2016-12-20
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT00867113 record still lists

NCT00867113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).

The record links to 0 conditions, and to 1 intervention - of which imatinib mesylate is the first listed.

NCT00867113 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00867113 about?

NCT00867113 is a clinical study titled "Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)". This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The purpose of this trial is to evaluate the use of long term adjuvant imatinib mesylate in patients at significant risk for recurrence following complete resection of primary GIST.

What is the current status of trial NCT00867113?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2009-07-22. Estimated completion is 2016-12-20.

What interventions are being tested in trial NCT00867113?

The interventions under investigation include: imatinib mesylate (DRUG).

Who is sponsoring clinical trial NCT00867113?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00867113's enrollment target sits among peer trials

91 771st of 2000 higher than 1,229 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00867113, the US trial registry maintained by the National Library of Medicine. NCT00867113 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.