Trials / Completed
CompletedNCT00135005
Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)
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)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMN107, STI571 |
Timeline
- Start date
- 2005-08-01
- Primary completion
- 2006-11-01
- Completion
- 2006-11-01
- First posted
- 2005-08-25
- Last updated
- 2020-12-08
Locations
5 sites across 4 countries: United States, France, Germany, Italy
Source: ClinicalTrials.gov record NCT00135005. Inclusion in this directory is not an endorsement.