Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib

A Multi-center Phase II Study to Evaluate the Efficacy and Safety of AMN107 (Nilotinib) in Patients With Gastrointestinal Stromal Tumors Who Have Progressed on or Are Intolerant to Both Imatinib and Sunitinib

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00718562

Enrollment

Registered

2008-07-18

Start date

2008-09-30

Completion date

2013-07-31

Last updated

2017-02-23

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

Conditions

Gastrointestinal Stromal Tumors

Keywords

nilotinib, AMN107, Sunitinib, Sunitinib malate, Imatinib, Imatinib mesylate, Tyrosine

Brief summary

This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.

Interventions

DRUGAMN107

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Documented disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib * At least one measurable site of disease on CT/MRI scan * PS≤2 * Normal organ, electrolyte, and bone marrow function

Exclusion criteria

* Previous treatment with nilotinib or any other drug in this class or other targeted therapy * Treatment with any cytotoxic and/or investigational drug ≤ 4 weeks prior to study entry * Impaired cardiac function * Use of coumarin derivatives (i.e. warfarin) * Women who are pregnant or lactating Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Disease Control Rate (DCR) in all patients with either sunitinib-resistant GIST or in patients with GIST who are intolerant of sunitinib	24 weeks

Secondary

Measure	Time frame
DCR in patients with sunitinib-resistant GIST, Progression free survival (PFS), overall survival (OS), Objective response rate (ORR)	24 weeks
Safety	24 weeks
PK profile	24 weeks

Countries

Japan

Outcome results

None listed

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