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Clinical Trial Details — Status: Approved for marketing

Administrative data

NCT number NCT00040625
Other study ID # 6093
Secondary ID H3E-US-JMFE
Status Approved for marketing
Phase Phase 2
First received July 2, 2002
Last updated March 14, 2007

Study information

Verified date March 2007
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical Trial Summary

This study is to evaluate the effects (good and bad) of ALIMTA and Cisplatin or ALIMTA alone on you and your malignant pleural mesothelioma as well as make ALIMTA available to patients who qualify for treatment.


Recruitment information / eligibility

Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Have a proven diagnosis of malignant mesothelioma in patients not candidates for curative surgery

- Prior chemotherapy for your disease is allowed

- Measurable lesion is not required

- Have a adequate performance status

- Sign an informed consent form

Exclusion Criteria:

- You are excluded from this trial if you have received any investigational agent within 4 week before enrolling in this study

- You are excluded from this trial if you have received radiation within the previous 2 weeks

- You are excluded from this trial if you are a candidates for curative surgery

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Drug:
Pemetrexed

Cisplatin


Locations

Country Name City State
Brazil For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician Porto Alegre RS
Brazil For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician Sao Paulo
Egypt "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician." Cairo
Egypt For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician Cairo
Saudi Arabia For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician Jeddah
United States For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician. Basking Ridge New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Brazil,  Egypt,  Saudi Arabia, 

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