Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients

Completed · Phase 1

Conditions studied: Small-Cell Lung Cancer

In brief

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 cancer (SCLC) who have not previously been treated with systemic chemotherapy.

Key facts

Study ID

NCT00466466

Run by

Novartis Pharmaceuticals

People needed

20

Starts

2007-04-01

Last updated by the study team

2020-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Highlands Oncology Group — Fayetteville, Arkansas, United States
• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Dana Faber Cancer Institute — Boston, Massachusetts, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Cancer Therapy and Research Center at UTHSCSA — San Antonio, Texas, United States
• Novartis Investigative Site — Paris, France

Full record on ClinicalTrials.gov

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