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

Small-Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00466466
• Other study ID #: CRAD001C2116
• Status: Completed
• Phase: Phase 1
• Start date: April 2007

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma
• Small-Cell Lung Cancer

Intervention

Drug:
• Everolimus
RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1		Day 21
Secondary	Relative dose intensity (RDI) of carboplatin and paclitaxel will be evaluated upon completion of the dose escalation within each regimen		within 6 cycles (Day 126)
Secondary	PK parameters derived from the PK profile of treatment drugs when administered alone or in combination will be evaluated during the first 6 cycles		During the first 6 cycles
Secondary	Overall tumor response		Every 6-8 weeks

External Links

•   Results for CRAD001C2116 can be found on the Novartis Clinical Trial Results Website