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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00785785
First received: November 4, 2008
Last updated: April 12, 2013
Last verified: April 2013
History of Changes

November 4, 2008
April 12, 2013
March 2009
October 2012   (final data collection date for primary outcome measure)
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 ]
To compare Progression Free Survival (PFS) of nilotinib and imatinib when used as initial therapy in patents with unresectable and/ or metastatic GIST. [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00785785 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To compare disease control rate (DCR) of nilotinib and imatinib [ Designated as safety issue: Yes ]
  • To compare time to treatment failure (TTF) of nilotinib and imatinib [ Designated as safety issue: Yes ]
  • To compare overall survival (OS) of nilotinib and imatinib [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study of Nilotinib Versus Imatinib in GIST Patients
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)

This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastrointestinal Stromal Tumor (GIST)
  • Drug: Nilotinib (AMN107)
  • Drug: imatinib (STI571)
    Other Name: Glivec/Gleevec
  • Experimental: Nilotinib
    Intervention: Drug: Nilotinib (AMN107)
  • Active Comparator: Imatinib
    Intervention: Drug: imatinib (STI571)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
791
June 2013
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Austria,   Brazil,   Bulgaria,   Canada,   China,   Colombia,   Czech Republic,   Denmark,   Egypt,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Poland,   Romania,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   United Kingdom,   Venezuela
 
NCT00785785
CAMN107G2301, 2008-004758-34
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP