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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00785785
Recruitment Status : Completed
First Posted : November 5, 2008
Results First Posted : April 7, 2016
Last Update Posted : June 16, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

November 4, 2008
November 5, 2008
October 21, 2015
April 7, 2016
June 16, 2016
March 2009
October 2014   (Final data collection date for primary outcome measure)
Time to Progression Free Survival (PFS) [ Time Frame: up to month 37 ]
PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
To compare Progression Free Survival (PFS) of nilotinib and imatinib when used as initial therapy in patents with unresectable and/ or metastatic GIST.
Complete list of historical versions of study NCT00785785 on Archive Site
Not Provided
  • To compare disease control rate (DCR) of nilotinib and imatinib
  • To compare time to treatment failure (TTF) of nilotinib and imatinib
  • To compare overall survival (OS) of nilotinib and imatinib
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A Study of Nilotinib Versus Imatinib in GIST Patients
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)
This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastrointestinal Stromal Tumor (GIST)
  • Drug: Nilotinib (AMN107)
  • Drug: imatinib (STI571)
    Other Name: Glivec/Gleevec
  • Experimental: Nilotinib
    nilotinib 400 mg twice a day
    Intervention: Drug: Nilotinib (AMN107)
  • Active Comparator: Imatinib
    imatinib 400 mg once daily
    Intervention: Drug: imatinib (STI571)
Blay JY, Shen L, Kang YK, Rutkowski P, Qin S, Nosov D, Wan D, Trent J, Srimuninnimit V, Pápai Z, Le Cesne A, Novick S, Taningco L, Mo S, Green S, Reichardt P, Demetri GD. Nilotinib versus imatinib as first-line therapy for patients with unresectable or metastatic gastrointestinal stromal tumours (ENESTg1): a randomised phase 3 trial. Lancet Oncol. 2015 May;16(5):550-60. doi: 10.1016/S1470-2045(15)70105-1. Epub 2015 Apr 14.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2014
October 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:

    • have not received any prior anti-neoplastic therapy other than adjuvant imatinib. Note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study or
    • recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies.
  2. At least one measurable site of disease on CT/MRI scan
  3. Performance status ≤ 2 (capable of self-care but unable to carry out any work)
  4. Normal organ, electrolyte and marrow function

Exclusion Criteria:

  1. Any prior anti-neoplastic therapy with the exception of patients who have received adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST whose disease requires therapy while awaiting entry to the study.
  2. Disease progression during adjuvant therapy with imatinib
  3. History of active malignancy (other than GIST) within 10 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
  4. Impaired cardiac function

Other protocol-defined inclusion/exclusion criteria may apply

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Brazil,   Bulgaria,   Canada,   China,   Colombia,   Czech Republic,   Denmark,   Egypt,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Poland,   Romania,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States,   Venezuela
Finland,   Greece
2008-004758-34 ( EudraCT Number )
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Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP