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

Gastrointestinal Stromal Tumors Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135005
• Other study ID #: CAMN107A2103
• Secondary ID: 2005-000561-18
• Status: Completed
• Phase: Phase 1
• Start date: August 2005
• Est. completion date: November 2006

Study information

• Verified date: May 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• AMN107, STI571

Locations

Country	Name	City	State
France	Novartis Investigative Site	Lyon Cedex
Germany	Novartis Investigative Site	Berlin
Italy	Novartis Investigative Site	Milano	MI
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MTD is defined to be the highest dose of AMN in combination with imatinib given for at least 21 days in the first treatment cycle	From day 1 cycle 1 until at least six subjects have been treated at the recommended dose level and observed for at least 21 days
Secondary	To characterize safety and tolerability of AMN107 in combination with Imatinib in GIST		From day 1 cycle to the study completion visit
Secondary	patients showing progression of disease on Imatinib. The patient will be followed-up for at least 4 cycles (28 days for one cycle)	cycle = 28 days	up to 4 cycles after disease profression on imatinib

External Links

•   Results for CAMN107A2103 can be found on the Novartis Clinical Trial Results Website