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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|