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

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 |
- 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

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

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

Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00785785 |
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 |
Unresectable GIST metastatic GIST nilotinib |
AMN107 imatinib STI571 |
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 |