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This study will explore the combination of the oral drug PF-00299804 and intravenous CP-751,871 in patients with advanced solid tumor. Each of these drugs have been given separately to patients in prior studies, and this study is to establish the safety and efficacy of the combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-00299804 | Drug | CP-751,871 at recommended dose on Day 1 and 2 of cycle 1, then on Day 1 every 3 weeks; and PF-00299804 orally at recommended dose once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall safety profile characterized by type, frequency, severity (as graded using NCI CTC AE v. 3.0), timing, seriousness and relationship to trial treatment of adverse events and laboratory abnormalities. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Pharmacokinetic Parameters of PF-00299804 and CP-751,871 | 12 months | |
| Progression Free Survival (PFS) | 15 months | |
| Best overall response (OR) defined according to RECIST guidelines. |
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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 | Amherst | New York | 14221 | 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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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009385 | Neoplastic Processes |
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| ID | Term |
|---|---|
| C525726 | dacomitinib |
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| 12 months |
| Duration of response (DR) | 15 months |
| Anti-Drug Antibodies (ADA) response; | 18 months |
| KRAS mutation and EGFR gene amplification and mutation status in available NSCLC tumor tissue (fresh or archived) (NSCLC MTD Expansion Cohort | 12 months |
| Buffalo |
| New York |
| 14263 |
| United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Villejuif | 94805 | France |
| Pfizer Investigational Site | Madrid | 28050 | Spain |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |