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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00321308 |
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Date of registration:
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02/05/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer
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Scientific title:
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A Randomized Phase II Trial Of Pemetrexed With Or Without PF-3512676 For The Treatment Of Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer After Failure Of One Prior Chemotherapy Regimen For Advanced Disease |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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36 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00321308 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Germany
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Italy
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Locally advanced or metastatic NSCLC
- Measurable disease
- ECOG PS 0 or 1
Exclusion Criteria:
- Known CNS metastasis
- Pre-existing autoimmune or antibody mediated disease
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carcinoma, Non-Small Cell Lung
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Intervention(s)
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Drug: pemetrexed
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Drug: pemetrexed + PF-3512676
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Primary Outcome(s)
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Progression-free survival
[Time Frame: 110 Events]
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Secondary Outcome(s)
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Overall Safety Profile
[Time Frame: 28 days post treatment]
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Patient Reported Outcome
[Time Frame: End of Treatment]
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Time to Tumor Progression
[Time Frame: End of treatment]
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Overall Survival
[Time Frame: Time of death]
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Duration of Response
[Time Frame: Time of disease progression]
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Overall Objective Response Rate
[Time Frame: Time of disease progressive disease]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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