Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)
Completed · Phase 1
Conditions studied: Gastrointestinal Stromal Tumors
In brief
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.
Key facts
- Study ID
- NCT00135005
- Run by
- Novartis Pharmaceuticals
- People needed
- 59
- Starts
- 2005-08-01
- Expected to finish
- 2006-11-01
- Last updated by the study team
- 2020-12-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Novartis Investigative Site — Boston, Massachusetts, United States
- Novartis Investigative Site — Philadelphia, Pennsylvania, United States
- Novartis Investigative Site — Lyon, France
- Novartis Investigative Site — Berlin, Germany
- Novartis Investigative Site — Milan, MI, Italy
Full record on ClinicalTrials.gov
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