NCT01486368

A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Pleural Mesothelioma

Interventions

Type	Name	Description
DRUG	PF-03446962	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.

Timeline

• Start date: 2012-06-26
• Primary completion: 2014-04-27
• Completion: 2015-02-13
• First posted: 2011-12-06
• Last updated: 2023-08-04

Locations

7 sites across 1 country: Canada