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

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ClinicalTrials.gov Identifier: NCT00785785

Recruitment Status : Completed

First Posted : November 5, 2008

Results First Posted : April 7, 2016

Last Update Posted : June 16, 2016

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

Study Description

Brief Summary:

This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

Condition or disease	Intervention/treatment	Phase
Gastrointestinal Stromal Tumor (GIST)	Drug: Nilotinib (AMN107) Drug: imatinib (STI571)	Phase 3

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	644 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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)
Study Start Date :	March 2009
Actual Primary Completion Date :	October 2014
Actual Study Completion Date :	October 2014

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gastrointestinal stromal tumor

Drug Information available for: Imatinib Imatinib mesylate Nilotinib

Genetic and Rare Diseases Information Center resources: Gastrointestinal Stromal Tumors

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nilotinib nilotinib 400 mg twice a day	Drug: Nilotinib (AMN107)
Active Comparator: Imatinib imatinib 400 mg once daily	Drug: imatinib (STI571) Other Name: Glivec/Gleevec

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
At least one measurable site of disease on CT/MRI scan
Performance status ≤ 2 (capable of self-care but unable to carry out any work)
Normal organ, electrolyte and marrow function

Exclusion Criteria:

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.
Disease progression during adjuvant therapy with imatinib
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.
Impaired cardiac function

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785785

Show 165 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00785785 History of Changes
Other Study ID Numbers:	CAMN107G2301 2008-004758-34 ( EudraCT Number )
First Posted:	November 5, 2008 Key Record Dates
Results First Posted:	April 7, 2016
Last Update Posted:	June 16, 2016
Last Verified:	May 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):


Unresectable GIST metastatic GIST nilotinib	AMN107 imatinib STI571

Additional relevant MeSH terms:


Gastrointestinal Stromal Tumors Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms	Digestive System Diseases Gastrointestinal Diseases Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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