Safety of Everolimus and Pemetrexed in Lung Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00434174
First received: February 9, 2007
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Everolimus
Drug: Pemetrexed
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: December 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434174

Locations
Australia, New South Wales
Novartis Investigative Site
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Novartis Investigative Site
Melbourne, Victoria, Australia, 3002
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
Germany
Novartis Investigative Site
Hamburg, Germany, 20246
Novartis Investigative Site
Koeln, Germany, 50924
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00434174     History of Changes
Other Study ID Numbers: CRAD001C2112, 2006-002759-34
Study First Received: February 9, 2007
Last Updated: December 18, 2012
Health Authority: United States: Food and Drug Administration
Belgium: DGG - Directoraat Generaal Geneesmiddelen, Dept. Onderzoek & Ontwikkeling
Germany: Federal Institute for Drugs and Medical Devices
Australia: Therapeutic Goods Administration

Keywords provided by Novartis:
Lung cancer
Non small cell lung cancer
NSCLC
RAD001
Everolimus
Afinitor
Pemetrexed

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Everolimus
Sirolimus
Pemetrexed
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 15, 2014