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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00785785
First received: November 4, 2008
Last updated: March 13, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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:
  • To compare Progression Free Survival (PFS) of nilotinib and imatinib when used as initial therapy in patents with unresectable and/ or metastatic GIST. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare disease control rate (DCR) of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To compare time to treatment failure (TTF) of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To compare overall survival (OS) of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To compare time to progression (TTP), response rate (RR), time to tumor response and assess duration of response of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To compare safety and tolerability of nilotinib and imatinib [ Time Frame: at month 1 and then every 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 736
Study Start Date: March 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Drug: Nilotinib (AMN107)
Active Comparator: Imatinib Drug: imatinib (STI571)
Other Name: Glivec/Gleevec

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785785

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 230 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00785785     History of Changes
Other Study ID Numbers: CAMN107G2301, 2008-004758-34
Study First Received: November 4, 2008
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Federal Office for Safety in Health Care
Brazil: National Health Surveillance Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada
China: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Romania: State Institute for Drug Control
Denmark: Danish Medicines Agency
Egypt: Ministry of Health and Population
Finland: Finnish Medicines Agency
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Greece: National Organization of Medicines
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: National Institute of Health
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Ministry of Health, Welfare and Sport
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
South Africa: Department of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan: Department of Health
Thailand: local IRB
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Venezuela:Instituto Nacional de Higiene "Rafael Rangel"

Keywords provided by Novartis:
Unresectable GIST
metastatic GIST
nilotinib
AMN107
imatinib
STI571

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014