Gastrointestinal Stromal Tumors
Conditions
Keywords
GIST, AMN107, Gastrointestinal Stromal Tumors
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.
Interventions
DRUGAMN107, STI571
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France, Germany, Italy, United States
Outcome results
None listed