Safety of Everolimus and Pemetrexed in Lung Cancer Patients - Full Text View

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:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Sirolimus Pemetrexed Pemetrexed disodium Everolimus Temsirolimus

U.S. FDA Resources

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

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 (Adult, Senior)
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


Responsible Party:	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:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Everolimus Sirolimus Pemetrexed	Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016