Trial record 2 of 175 for:    "gastrointestinal stromal tumor"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01110668
First received: April 22, 2010
Last updated: November 9, 2012
Last verified: November 2012
  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: 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:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01110668     History of Changes
Other Study ID Numbers: CAMN107DTR01T
Study First Received: April 22, 2010
Last Updated: November 9, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Novartis:
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

ClinicalTrials.gov processed this record on July 31, 2014