Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT00135005
Eligibility Criteria:
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 exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00135005
Study Brief:
Protocol Section:
NCT00135005