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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00785785
First received: November 4, 2008
Last updated: May 10, 2016
Last verified: May 2016
  Purpose
This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Novartis:

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


Enrollment: 644
Study Start Date: March 2009
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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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Please refer to this study by its ClinicalTrials.gov identifier: 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):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00785785     History of Changes
Other Study ID Numbers: CAMN107G2301
2008-004758-34 ( EudraCT Number )
Study First Received: November 4, 2008
Results First Received: October 21, 2015
Last Updated: May 10, 2016

Keywords provided by Novartis:
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

ClinicalTrials.gov processed this record on April 21, 2017