A Phase Ib Study Investigating the Combination of RAD001 With Cisplatin and Etoposide in Patients With Extensive-stage Small-cell Lung Cancer Not Previously Treated With Chemotherapy
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Small-Cell Lung Cancer
Both
Small-Cell Lung Cancer
Trial Information
A Phase Ib Study Investigating the Combination of RAD001 With Cisplatin and Etoposide in Patients With Extensive-stage Small-cell Lung Cancer Not Previously Treated With Chemotherapy
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1
Outcome Time Frame:
Day 21
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CRAD001C2116
NCT ID:
NCT00466466
Start Date:
April 2007
Completion Date:
Related Keywords:
- Small-cell Lung Cancer
- Small-Cell Lung Cancer
- SCLC
- Advanced Lung Cancer
- RAD
- RAD001
- Chemotherapy
- Cisplatin
- Etoposide
- Lung Neoplasms
- Small Cell Lung Carcinoma
Name | Location |
|---|---|
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| Highlands Oncology Group | Springdale, Arkansas 72764 |
| University of Colorado Health Sciences Center | Denver, Colorado 80262 |
| Dana Faber Cancer Institute | Boston, Massachusetts 02115 |
| Cancer Therapy and Research Center at UTHSCSA | San Antonio, Texas 78229 |
