Status:
COMPLETED
Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00135005
Start Date
August 1 2005
End Date
November 1 2006
Last Update
December 8 2020
Active Locations (5)
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1
Novartis Investigative Site
Boston, Massachusetts, United States, 02115
2
Novartis Investigative Site
Philadelphia, Pennsylvania, United States, 19111-2497
3
Novartis Investigative Site
Lyon, France, 69373
4
Novartis Investigative Site
Berlin, Germany, 13125