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Multicenter, Single-arm, Two Stage Phase II Trial of RAD001 (Everolimus) With Imatinib in Imatinib-resistant Patients With Progressive GIST

Phase 4
30 Years
80 Years
Not Enrolling
Progressive Gastrointestinal Stromal Tumor

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Trial Information

Multicenter, Single-arm, Two Stage Phase II Trial of RAD001 (Everolimus) With Imatinib in Imatinib-resistant Patients With Progressive GIST

Inclusion Criteria

Inclusion criteria:

1. Histological proven diagnosis of GIST

2. Objectively documented evidence of progressive disease according to the RECIST
criteria despite at least 2 months' continuous treatment with Imatinib mesylate at a
dosage of 400 mg/day

3. Clinical evidence of resistance to Imatinib mesylate on treatment with 400 mg/day

4. 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

5. At least one measurable lesion (longest diameter ≥ 20 mm on conventional CT or MRI
scan; ≥ 10 mm on spiral CT)

6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

7. Adequate bone marrow, liver and renal function on Imatinib treatment

8. Patients must be at least 4 weeks since prior major surgery and recovered, at least 2
weeks since prior minor surgery and recovered

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

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 Imatinib

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

Other protocol defined inclusion/ exclusion criteria may apply

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor assessments should be performed by a CT or MRI scan after 4 months. Response to treatment with RAD001 plus Imatinib mesylate at 4 months (defined as progression-free survival (PFS) at 4 months).

Outcome Time Frame:

at 4 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

October 2006

Completion Date:

October 2012

Related Keywords:

  • Progressive Gastrointestinal Stromal Tumor
  • Progressive GIST
  • Resistance to Imatinib mesylate
  • Gastrointestinal Stromal Tumors