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NCT01468688 · ClinicalTrials.gov registry record · Phase 1

A Dose-finding Study of a Combination of Imatinib and BKM120 in the Treatment of 3rd Line GIST Patients

A Phase 1 study of 3rd Line GIST, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target
11
Study locations

NCT01468688 is a Phase 1 study of 3rd Line GIST that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 60 participants. The trial reports 11 study locations across 6 states.

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The verdict

NCT01468688, a Phase 1 study of 3rd Line GIST, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target
11
Study locations

Study Summary

The purpose of this study is to determine a maximum tolerated dose and/or recommended phase 2 dose of a combination of imatinib and BKM120 in the treatment of 3rd line GIST patients.

Conditions Studied

Interventions

  • DRUG BKM120
  • DRUG STI571

Study Locations (11)

Other

  • Novartis Investigative Site - Leuven
  • Novartis Investigative Site - Lyon
  • Novartis Investigative Site - Villejuif
  • Novartis Investigative Site - Leiden
  • Novartis Investigative Site - London
  • Novartis Investigative Site - Manchester

Massachusetts

  • Dana Farber Cancer Institute SC (2) - Boston

Washington

  • Seattle Cancer Care Alliance Onc - Seattle

British Columbia

  • Novartis Investigative Site - Vancouver

Chiba

  • Novartis Investigative Site - Kashiwa

Catalonia

  • Novartis Investigative Site - Barcelona

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2012-04-20
Est. Completion 2016-07-29
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01468688

The ClinicalTrials.gov registry entry for NCT01468688 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with 3rd Line GIST appearing as the primary indexed condition, and to 2 interventions - of which BKM120 is the first listed.

NCT01468688 reports 11 study locations spanning 6 distinct geographic areas - top geographies include Other, Massachusetts, Washington.

Frequently Asked Questions

What is clinical trial NCT01468688 about?

NCT01468688 is a clinical study titled "A Dose-finding Study of a Combination of Imatinib and BKM120 in the Treatment of 3rd Line GIST Patients". The purpose of this study is to determine a maximum tolerated dose and/or recommended phase 2 dose of a combination of imatinib and BKM120 in the treatment of 3rd line GIST patients.

What is the current status of trial NCT01468688?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2012-04-20. Estimated completion is 2016-07-29.

What conditions does trial NCT01468688 study?

This clinical trial studies the following conditions: 3rd Line GIST.

What interventions are being tested in trial NCT01468688?

The interventions under investigation include: BKM120 (DRUG), STI571 (DRUG).

Who is sponsoring clinical trial NCT01468688?

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

Where is trial NCT01468688 being conducted?

This trial has 11 study locations across Massachusetts, Washington, British Columbia, Chiba, Catalonia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.