Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastrointestinal Stromal Tumors
Intervention: AMN107, STI571 (Drug)
Phase: Phase 1
Sponsored by: Novartis
Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis
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.
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)
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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
To characterize safety and tolerability of AMN107 in combination with Imatinib in GIST
patients showing progression of disease on Imatinib. The patient will be followed-up for at least 4 cycles (28 days for one cycle)
Minimum age: 18 Years.
Maximum age: N/A.
- 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.
- 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
- 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.
Locations and Contacts
Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States
Novartis Clinical Trials Listing
Starting date: August 2005
Last updated: December 7, 2007