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Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01110668
First Posted: April 27, 2010
Last Update Posted: February 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will assess time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.

Condition Intervention Phase
Gastrointestinal Stromal Tumor Drug: Nilotinib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST) Previously Treated With Imatinib

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • To evaluate time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg. [ Time Frame: every 8 weeks ]

Secondary Outcome Measures:
  • To determine progression-free survival and the response rate of nilotinib in patients with advanced GIST previously treated with imatinib ≥600 mg. [ Time Frame: 6 months ]

Enrollment: 2
Study Start Date: September 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Drug: Nilotinib

  Eligibility

Information from the National Library of Medicine

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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:

  • Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic
  • Radiological confirmation of disease progression or intolerance to imatinib therapy at a any dose
  • At least one measurable site of disease on CT scan at Visit-2
  • WHO Performance Status of 0, 1 or 2 at Visit-2
  • Patients must have normal organ, electrolyte, and marrow function at Visit-1 and Visit-2

Exclusion Criteria:

  • Prior treatment with nilotinib or any other tyrosine kinase inhibitors except imatinib.
  • Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks
  • Prior or concomitant malignancies other than GIST
  • Impaired cardiac function at Visit-1 or 2
  • Patients with severe and/or uncontrolled concurrent medical disease
  • Use of therapeutic coumarin derivatives
  • Use of any medications that prolong the QT interval
  • Use of CYP3A4 inhibitors
  • Patients who have undergone major surgery ≤ 2 weeks prior to Visit-1 or who have not recovered from side effects of such surgery
  • Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks prior to Visit-1 or who have not recovered from side effects of such therapy

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Information from the National Library of Medicine

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): NCT01110668


Locations
Turkey
Novartis Investigative Site
Adana, Turkey
Novartis Investigative Site
Ankara, Turkey
Novartis Investigative Site
Istanbul, Turkey
Novartis Investigative Site
Izmir, Turkey
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01110668     History of Changes
Other Study ID Numbers: CAMN107DTR01T
First Submitted: April 22, 2010
First Posted: April 27, 2010
Last Update Posted: February 28, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Unresectable
metastatic gastrointestinal stromal tumor
disease progression
progression-free survival

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