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Completed

NCT Number: NCT00434174

Safety of Everolimus and Pemetrexed in Lung Cancer Patients

This study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer.

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Lung cancer
  • Only one prior regimen of chemotherapy for the treatment of non small cell lung cancer
  • Adequate bone marrow function
  • Adequate liver function
  • Adequate renal function
  • Negative serum pregnancy test

Exclusion criteria

  • History of another primary malignancy in the last 5 years
  • Having recently received an investigational drug
  • Having recently received major surgery of wide field radiotherapy
  • Chronic treatment with immunosuppressive therapy, steroids or liver enzyme modulators
  • Severe or uncontrolled medical conditions

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. All proposed dose levels in this study can be given as a combination of these dose strengths.

Daily doses of 2.5, 5, 7.5 and 10 mg of RAD001 will be given alongside the standard 21-day cycle of pemetrexed.

Other names: RAD001, Affinitor

Pemetrexed

Drug

Pemetrexed was supplied to the sites in 500 mg/m2 was administered on Day 1 of each cycle as a 10-minute continuous i.v. infusion in 100mL normal saline

Primary outcomes

  1. Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.

    Time frame: Over 18 weeks of combination treatment

Secondary outcomes

  1. Assess the ability to deliver the standard pemetrexed treatment (relative dose intensity) Assess the pharmacokinetics of everolimus and chemotherapy Evaluate the effect of therapy (RECIST)

    Time frame: Over 18 weeks of combination treatment

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Phase I Study Investigating the Combination of Everolimus With Pemetrexed in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Previously Treated With Chemotherapy

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Feb 13, 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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