Safety of Everolimus and Pemetrexed in Lung Cancer Patients

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

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

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Everolimus; Drug: Pemetrexed

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Novartis Investigative Site
  • Victoria
    • Melbourne, Victoria, Australia, 3002
      • Novartis Investigative Site
• Belgium
  • Leuven, Belgium, 3000
    • Novartis Investigative Site
• Germany
  • Hamburg, Germany, 20246
    • Novartis Investigative Site
  • Koeln, Germany, 50924
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: everolimus + Pemetrexed - daily; Daily treatment	Drug: Everolimus; 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; Drug: Pemetrexed; 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
Experimental: everolimus + Pemetrexed - weekly; Weekly treatment	Drug: Everolimus; 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; Drug: Pemetrexed; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.	Over 18 weeks of combination treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	Over 18 weeks of combination treatment

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CRAD001C2112 can be found on the Novartis Clinical Trial Results Website

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: February 9, 2007
• First Submitted That Met QC Criteria: February 9, 2007
• First Posted (Estimate): February 13, 2007

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: NSCLC; Lung cancer; Everolimus; Pemetrexed; Non small cell lung cancer; RAD001; Afinitor
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Folic Acid Antagonists; Pemetrexed; Everolimus
• Other Study ID Numbers: CRAD001C2112; 2006-002759-34