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See Termination Reason in Detailed Description.
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To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC who have failed one prior chemotherapy regimen
PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. The decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment and protocol follow-up. Data collection was completed on 31 January 2008.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Active Comparator | Standard of care chemotherapy |
|
| A | Experimental | Standard of care chemotherapy plus experimental intervention (PF-3512676) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 110 Events |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time of death | |
| Overall Safety Profile | 28 days post treatment | |
| Patient Reported Outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Litchfield Park | Arizona | 85340 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| pemetrexed + PF-3512676 | Drug | pemetrexed 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity |
|
|
| End of Treatment |
| Time to Tumor Progression | End of treatment |
| Overall Objective Response Rate | Time of disease progressive disease |
| Duration of Response | Time of disease progression |
| Sun City |
| Arizona |
| 85351 |
| United States |
| Pfizer Investigational Site | Bentonville | Arkansas | 72712 | United States |
| Pfizer Investigational Site | Fayetteville | Arkansas | 72703 | United States |
| Pfizer Investigational Site | Hudson | Florida | 34667 | United States |
| Pfizer Investigational Site | New Port Richey | Florida | 34655 | United States |
| Pfizer Investigational Site | Mahwah | New Jersey | 07430 | United States |
| Pfizer Investigational Site | Midland Park | New Jersey | 07432 | United States |
| Pfizer Investigational Site | Paramus | New Jersey | 07652 | United States |
| Pfizer Investigational Site | Westwood | New Jersey | 07675 | United States |
| Pfizer Investigational Site | Oneida | New York | 13421 | United States |
| Pfizer Investigational Site | Oswego | New York | 13126 | United States |
| Pfizer Investigational Site | Syracuse | New York | 13210-2306 | United States |
| Pfizer Investigational Site | Syracuse | New York | 13210 | United States |
| Pfizer Investigational Site | Sylvania | Ohio | 43560 | United States |
| Pfizer Investigational Site | Seattle | Washington | 89109 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98195 | United States |
| Pfizer Investigational Site | Großhansdorf | 22927 | Germany |
| Pfizer Investigational Site | Mannheim | 68167 | Germany |
| Pfizer Investigational Site | Torino | 10126 | Italy |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| C483020 | ProMune |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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