gastrointestinal stromal tumors (GIST)
Conditions
Interventions
Product Name: Certican Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
Current Sponsor code: RAD001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years 2. Histologically proven diagnosis of GIST 3. Objectively documented evidence of progressive disease according to the RECIST criteria despite at least 2 months' continuous treatment with Glivec® at a dosage of 400 mg/day. A treatment period of 2 weeks before study entry with an increased dosage of Glivec due to progression is allowed. 4. Clinical evidence of resistance to Glivec® on treatment with 400 mg/day Glivec® 5. Progression must be documented on CT or MRI scans. The scans on which progression is documented should be at maximum 2 weeks old. New scans are only required as baseline scans if they are older then approx. 2 weeks 6. At least one measurable lesion (longest diameter >= 20 mm on conventional CT or MRI scan; >= 10 mm on spiral CT) 7. ECOG Performance Status 0-2 8. Adequate bone marrow, liver and renal function on Glivec® treatment 9. Patients must be at least 4 weeks since prior major surgery and recovered, at least 2 weeks since prior minor surgery and recovered 10. Written informed consent must be obtained prior to any screening procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Female patients who are pregnant or breast feeding, or patients of reproductive potential not employing an effective method of birth control. Because oral, implantable or injectable contraceptives may be affected by cytochrome P450 interactions, an appropriate method of birth control should be used throughout the trial in both sexes. Women of childbearing potential must have a negative serum pregnancy test <= 48 hours prior to the administration of study medication 2. Patients presenting with known or symptomatic CNS metastases or leptomeningeal involvement 3. Use of other investigational cancer therapies within 28 days prior to enrollment or which are currently being or planned to be received during the course of the study 4. Patients who previously received rapamycin in combination with Glivec® 5. 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 within 6 months, unstable angina, chronic or acute renal or liver disease, uncontrolled infections including abscess or fistulae, etc.) 6. 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 7. Patients receiving glucocorticoids (only if the p70s6 kinase-1 assay is being performed), since glucocorticoids have been shown to inhibit p70s6 kinase-1 activity 8. Patients unwilling to or unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the response to treatment with RAD001 plus Glivec® at 4 months. Response is defined as progression-free survival (PFS) at 4 months.;Secondary Objective: • To assess the tolerability and safety profile of the combination • To assess the objective tumor response rate (complete response [CR] and partial response [PR]) • To assess PFS at 4 months • To assess PFS at month12 for patients with data available from follow up observation (optional) • To assess the relationship between clinical outcome and changes in molecular pathology ;Primary end point(s): The primary variable is the rate of patients achieving progression-free survival at 4 months. | — |
Countries
Germany
Outcome results
None listed