Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)

Novartis

Status and phase

Completed

Phase 1

Conditions

Gastrointestinal Stromal Tumors

Treatments

Drug: AMN107, STI571

Study type

Interventional

Funder types

Industry

Identifiers

NCT00135005

2005-000561-18 (EudraCT Number)

CAMN107A2103

Details and patient eligibility

About

This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with gastrointestinal stromal tumor (GIST).
Patients who have had disease progression during imatinib therapy with 800 mg.
Ability to understand and willingness to sign a written informed consent document.

Exclusion criteria

Patients with prior or concomitant malignancies other than GIST with the exception of previous or concomitant basal cell skin cancer or previous cervical carcinoma in situ.
A history of impaired cardiac function or uncontrolled cardiovascular disease.
Severe and/or uncontrolled concurrent disease that could cause unacceptable safety risks such as impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AMN107.
Currently taking certain medications that could affect an electrocardiogram result.
Women who are pregnant or breast feeding.
Patients unwilling or unable to comply with the protocol.

NOTE: Additional inclusion and/ or exclusion criteria may apply.