Status:
COMPLETED
Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Small-Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study aims to establish a tolerable dose level and regimen of RAD001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung c...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with histologically or cytologically confirmed diagnosis of extensive disease small-cell lung cancer (ED SCLC)
- Age ≥ 18 years
- WHO Performance Status Grade ≤ 1 (ie. ability to perform normal daily functions)
- Adequate bone marrow, liver and renal function
- Exclusion criteria:
- Chronic steroid treatment
- Prior treatment with chemotherapy for advanced lung cancer
- Prior treatment with mTOR inhibitors
- Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions, chronic liver or kidney disorders, uncontrolled diabetes, infections or other severe medical conditions
- Symptomatic or uncontrolled brain metastases
- Other cancers within the past 5 years
- Pregnant or breastfeeding women
- Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00466466
Start Date
April 1 2007
Last Update
December 21 2020
Active Locations (6)
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1
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
2
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
3
Dana Faber Cancer Institute
Boston, Massachusetts, United States, 02115
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009