Completed PHASE3 INTERVENTIONAL 2-arm NCT00785785

A Study of Nilotinib Versus Imatinib in GIST Patients (ENESTg1)

A Randomized, Open Label, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Nilotinib Versus Imatinib in Adult Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)

Sponsor: Novartis Pharmaceuticals

Conditions Gastrointestinal Stromal Tumor (GIST)

Interventions Nilotinib (AMN107) imatinib (STI571)

Updated 7 times since 2017 Last updated: May 10, 2016 Started: Mar 31, 2009 Primary completion: Oct 31, 2014 Completion: Oct 31, 2014

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Gastrointestinal Stromal Tumor (GIST), this trial is completed. The trial is conducted by Novartis Pharmaceuticals and has accumulated 7 data snapshots since 2009. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Mar 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Novartis Pharmaceuticals

Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Adana, Turkey (Türkiye) , Alexandria, Egypt , Ankara, Turkey (Türkiye) , Ann Arbor, United States , Aurora, United States , Aviano, Italy , Bad Saarow, Germany , Balcova / Izmir, Turkey (Türkiye) , Bangkok, Thailand , Barcelona, Spain and 140 more locations