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

Phase 1

Completed

• Conditions: Gastrointestinal Stromal Tumors
• Interventions: Drug: AMN107, STI571

• Registration Number: NCT00135005
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-23
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-25
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2013-05
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMN107 + STI571	AMN107, STI571	-

Primary Outcome Measures

Name	Time	Method
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	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	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

Secondary Outcome Measures

Name	Time	Method
To characterize safety and tolerability of AMN107 in combination with Imatinib in GIST	From day 1 cycle to the study completion visit
patients showing progression of disease on Imatinib. The patient will be followed-up for at least 4 cycles (28 days for one cycle)	up to 4 cycles after disease profression on imatinib	cycle = 28 days

Trial Locations

Locations (1)

Novartis Investigative Site; 🇮🇹 Milano, MI, Italy