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Completed

NCT Number: NCT00457119

Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients

This 2 step study aims to establish a tolerable dose level and regimen of RAD001 in patients with advanced NCLC not previously treated with systemic therapy. In step 1 of this study, RAD 001 is given in combination with carboplatin and paclitaxel and in Step 2 RAD001 is given in combination with carboplatin, paclitaxel and bevacizumab

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Key information

Conditions

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

Age range

23 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Adelaide, South Australia, Australia

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About this study

This is a two-step, open-label, multi-center, dose escalation Phase 1 study in which RAD001 is administered in combination with carboplatin and paclitaxel (CP) in Step 1 as well as carboplatin, paclitaxel, and bevacizumab (CPB) in Step 2 in patients with advanced (unresectable or metastatic) NSCLC not treated previously with systemic therapy for advanced disease

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age over 18 years
  • Advanced Non Small Cell Lung Cancer (Stage IIIB/IV)
  • Ability to perform normal daily functions

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
  • Known sensitivity to platinum compounds, taxanes or bevacizumab
  • Other cancers within the past 5 years
  • Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

RAD001

Drug

5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm

Other names: Everolimus

Primary outcomes

  1. Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate

    Time frame: Ever 3 months or once a critical DLT occurs

Secondary outcomes

  1. Relative dose intensity (RDI) of Carboplatin + Paclitaxel (step 1)

    Time frame: End of step 1

  2. Relative dose intensity (RDI) of Carboplatin + Paclitaxel + bevacizumab (step 2)

    Time frame: End of Step 2

  3. PK parameters derived from PK profiles of treatment drugs alone and in combination

    Time frame: End of Step 1 and Step 2

  4. Best overall response - measured by CT/MRI scan every 6-8 week

    Time frame: Every 6-8 week

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Two-step Phase 1 Study Investigating the Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients Not Treated Previously With Systemic Therapy

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 5, 2007
Registry last updated
Feb 12, 2013

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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