Safety of Everolimus and Pemetrexed in Lung Cancer Patients
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
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
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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:
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:
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
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 Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 16, 2013