Trial Information

Summary: A Phase I-II, Open Label Study of RAD001 in Combination with Glivec®/Gleevec™ (Imatinib) in Patients with Glivec/Gleevec-Refractory/Resistant Gastrointestinal Stromal Tumors

This study will test the addition of RAD001 to Gleevec™ to determine if it is safe and has beneficial effects in people whose disease progresses despite higher doses (more than 600mg) of Gleevec™. RAD001 is a drug (taken by mouth) that is being considered as possible treatment for cancer. The combination of RAD001 and Gleevec™ is investigational. Your decision to take part in this study is voluntary. If you decide to take part, you are also free to leave the study at any time. If you choose not to join in this study, you can discuss regular medical care with the study doctor.

Patient Inclusion Criteria

• Patients must have given informed consent in accordance with GCPs and local regulatory requirements
• Age 18 years
• Patient must have a histologically proven diagnosis of GIST
• Patients must have at least one measurable lesion
• Patients must have a WHO Performance Status Score 2
• Patients must be at least 4 weeks since prior major surgery and recovered, at least 2 weeks since prior minor surgery and recovered
• Patients must have adequate bone marrow, liver and renal function on Glivec/Gleevec treatment
• Patients must have objectively documented of evidence resistance to Glivec/Gleevec

Patient Exclusion Criteria

• Women who are pregnant or breast-feeding
• Sexually active patients unwilling to employ a medically approved method of birth control
• Patients presenting with known or symptomatic CNS metastases or leptomeningealinvolvement
• Patients who are planning to receive other investigational or commercialized cancer therapies while participating in the study
• Patients who previously received Rapamycin in combination with Glivec/Gleevec
• Patients with any concurrent major medical condition liable to compromise the patient's participation in the study (e.g. known HIV infection, uncontrolled diabetes, serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure, myocardial infarction with 6 months, unstable angina, chronic or acute renal or liver disease, uncontrolled infections including abscess or fistulae, etc.)
• Patients with a history of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer
• Patients unwilling to or unable to comply with the protocol
• Patients who are receiving glucocorticoids (only if the p70s6 kinase1 assay is being performed), since these have been shown to inhibit p70s6 kinase1 activity.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.