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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.

Outcome Time Frame:

Over 18 weeks of combination treatment

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001C2112

NCT ID:

NCT00434174

Start Date:

December 2006

Completion Date:

December 2010

Related Keywords:

  • Non Small Cell Lung Cancer
  • Lung cancer
  • Non small cell lung cancer
  • NSCLC
  • RAD001
  • Everolimus
  • Afinitor
  • Pemetrexed
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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