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

Study Description

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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

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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

Arms and Interventions

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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

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Primary Outcome Measures :

1. 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

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

Criteria

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

Contacts and Locations

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  Show 165 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

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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
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