Safety of Everolimus and Pemetrexed in Lung Cancer Patients
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| ClinicalTrials.gov Identifier: NCT00434174 |
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Recruitment Status :
Completed
First Posted : February 13, 2007
Last Update Posted : December 21, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non Small Cell Lung Cancer | Drug: Everolimus Drug: Pemetrexed | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 48 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Study Start Date : | December 2006 |
| Actual Primary Completion Date : | December 2010 |
| Actual Study Completion Date : | December 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: everolimus + Pemetrexed - daily
Daily treatment
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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 |
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Experimental: everolimus + Pemetrexed - weekly
Weekly treatment
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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 |
- 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 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434174
| 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 | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals | |
| Study Chair: | Novartis | Novartis |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00434174 |
| Other Study ID Numbers: |
CRAD001C2112 2006-002759-34 |
| First Posted: | February 13, 2007 Key Record Dates |
| Last Update Posted: | December 21, 2020 |
| Last Verified: | December 2012 |
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Lung cancer Non small cell lung cancer NSCLC RAD001 |
Everolimus Afinitor Pemetrexed |
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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 Pemetrexed Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |