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

Gastrointestinal Stromal Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110668
• Other study ID #: CAMN107DTR01T
• Status: Completed
• Phase: Phase 2
• First received: April 22, 2010
• Last updated: February 24, 2017
• Start date: September 2008
• Est. completion date: September 2011

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Nilotinib

Locations

Country	Name	City	State
Turkey	Novartis Investigative Site	Adana
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib =600 mg.		every 8 weeks
Secondary	To determine progression-free survival and the response rate of nilotinib in patients with advanced GIST previously treated with imatinib =600 mg.		6 months

External Links

•   Results for CAMN107DTR01T from the Novartis Clinical Trials website