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

Condition(s) targeted: Gastrointestinal Stromal Tumors

Intervention: AMN107, STI571 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis

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.

Official title: A Phase I Multicenter, Dose Escalation Study of AMN107 in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST)

Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: To determine the MTD which will be the Phase II dose of AMN107 when given in combination with Imatinib. The MTD is defined to be the highest dose of AMN107 in combination with Imatinib given for at least 21 days in the first treatment cycle

Secondary outcome:

To characterize safety and tolerability of AMN107 in combination with Imatinib in GIST

patients showing progression of disease on Imatinib. The patient will be followed-up for at least 4 cycles (28 days for one cycle)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States

Novartis Clinical Trials Listing

Starting date: August 2005
Last updated: December 7, 2007