Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)
1 other identifier
interventional
2
1 country
4
Brief Summary
This study will assess time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2008
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 22, 2010
CompletedFirst Posted
Study publicly available on registry
April 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFebruary 28, 2017
February 1, 2017
3 years
April 22, 2010
February 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.
every 8 weeks
Secondary Outcomes (1)
To determine progression-free survival and the response rate of nilotinib in patients with advanced GIST previously treated with imatinib ≥600 mg.
6 months
Study Arms (1)
Nilotinib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Novartis Investigative Site
Adana, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, Turkey (Türkiye)
Novartis Investigative Site
Izmir, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2010
First Posted
April 27, 2010
Study Start
September 1, 2008
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
February 28, 2017
Record last verified: 2017-02