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NCT01089595 · ClinicalTrials.gov registry record · Phase 2

Trial of Tasigna (Nilotinib) 400 mg Twice Daily Alone or With Gleevec (Imatinib Mesylate) 400 mg Daily for Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

A Phase 2 study, sponsored by Fox Chase Cancer Center.

Terminated
Registry status
Phase 2
Development phase
5
Enrollment target

NCT01089595: Clinical Trial Phase 2 study, sponsored by Fox Chase Cancer Center.

NCT01089595 is a Phase 2 study that was terminated before completion, run by Fox Chase Cancer Center. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01089595, a Phase 2 study, was terminated before completion, sponsored by Fox Chase Cancer Center.

TERMINATED
Registry status
Phase 2
Development phase
5 participants
Enrollment target

Study Summary

Patients with advanced GIST are treated with imatinib. This study seeks to look at a new therapeutic agent at the time of tumor progression following treatment with 600-800 mg daily of imatinib. The study is looking to see if Nilotinib (tasigna) alone or in combination with imatinib (gleevec) is more effective at controlling disease.

Primary Outcome

Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression. It will be determined for both RECIST (Response Evaluation Criteria in Solid Tumors) and CHOI criteria.

Interventions

  • DRUG Nilotinib
  • DRUG Nilotinib with Imatinib

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2009-02
Est. Completion 2012-03
Phase Phase 2
Fox Chase Cancer Center

183 total trials

Why NCT01089595 stopped before completion

NCT01089595 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Nilotinib is the first listed.

NCT01089595 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01089595 about?

NCT01089595 is a clinical study titled "Trial of Tasigna (Nilotinib) 400 mg Twice Daily Alone or With Gleevec (Imatinib Mesylate) 400 mg Daily for Patients With Advanced Gastrointestinal Stromal Tumor (GIST)". Patients with advanced GIST are treated with imatinib. This study seeks to look at a new therapeutic agent at the time of tumor progression following treatment with 600-800 mg daily of imatinib. The study is looking to see if Nilotinib (tasigna) alone or in combination with imatinib (gleevec) is mor...

What is the current status of trial NCT01089595?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2009-02. Estimated completion is 2012-03.

What interventions are being tested in trial NCT01089595?

The interventions under investigation include: Nilotinib (DRUG), Nilotinib with Imatinib (DRUG).

Who is sponsoring clinical trial NCT01089595?

This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01089595's enrollment target sits among peer trials

5 2000th of 2000 the lowest 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 NCT01089595, the US trial registry maintained by the National Library of Medicine. NCT01089595 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.