A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01486368|
Recruitment Status : Completed
First Posted : December 6, 2011
Last Update Posted : September 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma||Drug: PF-03446962||Phase 2|
To assess the efficacy (response rate, complete and partial) of PF-03446962 given by IV infusion Day 1 of a 2 week cycle (14 days = 1 cycle) in patients with advanced malignant pleural mesothelioma and previously treated with cytotoxic therapy.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||February 2015|
PF-03446962 will be administered by IV infusion every 2 weeks (q2w). A cycle will be 2 weeks in duration and include one administration of PF-03446962.
- Response Rate [ Time Frame: 30 months ]Assessing the efficacy (response rate, complete and partial) of PF-03446962 given by IV infusion Day 1 of a 2 week cycle(14 days = 1 cycle) in patients with malignant pleural mesothelioma and previously treated with cytotoxic therapy.
- Amount and severity of adverse events [ Time Frame: 30 months ]To assess toxicity, safety and tolerability of PF-03446962.
- Duration of Response [ Time Frame: 30 months ]To assess the duration of response or stable disease, stable disease rate, progression-free survival, median and overall survival rates
- Blood and tissue marker evaluation [ Time Frame: 30 months ]Specimen collection to look for markers in cancer cells. These markers might help predict which patients are most likely to be helped by the study drug PF-03446962.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486368
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA - Fraser Valley Cancer Centre|
|Surrey, British Columbia, Canada, V3V 1Z2|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|Ottawa Health Research Institute - General Division|
|Ottawa, Ontario, Canada, K1H 8L6|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Quincy Chu||Cross Cancer Institute, Edmonton, AB Canada|
|Study Chair:||Paul Wheatley-Price||Ottawa Health Research Institute - General Division, Ottawa ON Canada|