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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01110668

Enrollment

Registered

2010-04-27

Start date

2008-09-30

Completion date

2011-09-30

Last updated

2017-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Stromal Tumor

Keywords

Unresectable, metastatic gastrointestinal stromal tumor, disease progression, progression-free survival

Brief summary

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

Interventions

DRUGNilotinib

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
To evaluate time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.	every 8 weeks

Secondary

Measure	Time frame
To determine progression-free survival and the response rate of nilotinib in patients with advanced GIST previously treated with imatinib ≥600 mg.	6 months

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026