Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-28 @ 9:38 AM
Study NCT ID:
NCT01486368
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2011-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma
Sponsor:
NCIC Clinical Trials Group
Organization:
Study Overview
Official Title:
A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a non-randomized open label multicentre Phase II trial to evaluate the response rate of PF03446962 in patients with advanced malignant pleural mesothelioma who have been previously treated with cytotoxic chemotherapy.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: