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OpenTrials
Completed

NCT Number: NCT00466466

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

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.

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Key information

Conditions

Small-cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Everolimus

Drug

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.

Other names: RAD001

Primary outcomes

  1. Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1

    Time frame: Day 21

Secondary outcomes

  1. Relative dose intensity (RDI) of carboplatin and paclitaxel will be evaluated upon completion of the dose escalation within each regimen

    Time frame: within 6 cycles (Day 126)

  2. PK parameters derived from the PK profile of treatment drugs when administered alone or in combination will be evaluated during the first 6 cycles

    Time frame: During the first 6 cycles

  3. Overall tumor response

    Time frame: Every 6-8 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
First posted
Apr 27, 2007
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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