A Randomized Phase 3 Trial Comparing ALIMTA Plus Best Supportive Care Versus Best Supportive Care Alone in Previously Treated Patients With Locally Advanced or Metastatic Malignant Pleural Mesothelioma
18 Years
N/A
Both
Mesothelioma
Trial Information
A Randomized Phase 3 Trial Comparing ALIMTA Plus Best Supportive Care Versus Best Supportive Care Alone in Previously Treated Patients With Locally Advanced or Metastatic Malignant Pleural Mesothelioma
Inclusion Criteria:
- Histologically proven diagnosis of mesothelioma of the pleura.
- received only one prior systemic chemotherapy regimen for advanced or metastatic
disease
- Performance status of 70 or higher on the Karnofsky Performance Status Scale
- Males or females at least 18 years of age
- Adequate organ function
Exclusion Criteria:
- Active infection that in the opinion of the investigator would compromise the
patient's ability to tolerate therapy
- Pregnancy or breastfeeding
- Brain metastasis
- Prior treatment with Pemetrexed
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary objective of this study is to compare the overall survival following treatment with Pemetrexed plus best supportive care versus best supportive care alone
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am-5pm Eastern time (UTC/GMT-5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
United States: Food and Drug Administration
Study ID:
5362
NCT ID:
NCT00190762
Start Date:
October 2001
Completion Date:
November 2005
Related Keywords:
- Mesothelioma
- Mesothelioma
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