Status: Closed
Activation Date: 2011NOV30
Closing Date: 2014JAN09
Phase: II
Description: A Phase II Study of PF-03446962 in Patients with Advanced Malignant Pleural Mesothelioma
Eligibility: histologically or cytologically confirmed malignant pleural mesothelioma; advanced and/or metastatic disease; at least one site of disease must be unidimensionally measurable; patients are eligible after first line cytotoxic chemotherapy has failed; patients must have received one, but no more than one, combination chemotherapy regimen for advanced disease, which must have contained platinum based chemotherapy
Objective: To assess the efficacy of PF-03446962 given by IV day 1 of a 2 week cycle in patients with advanced malignant pleural mesothelioma; to assess the toxicity, safety and tolerability of PF-03446962; to assess the duration of response or stable disease, stable disease rate, progression free, median and overall survival rates; to collect tissue and blood for banking and correlative science evaluation.
Participation: Limited to invited centres
Lay Description: The main purpose of this study is to find out how effective the experimental drug PF-03446962 is in treating patients with pleural mesothelioma who have been previously treated with cytotoxic therapy. In addition, this study will look at the side effects of PF-03446962, the duration of response or stable disease, stable disease rate, progression-free, median and overall survival rates. Additional research will investigate tissue and blood samples for correlative science evaluation.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I207 | 17 | 10 | 12 | 16 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I207 | 17 | 1 | 4 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I207 | 17 | 0 | 0 | 0 | 0 | 17 | 15 | 0 | 0 |