A Phase II Study of Single-agent DOVitinib in Advanced Malignant PlEural Mesothelioma Which Has Progressed Following Prior Platinum-Antifolate Chemotherapy

Phase 2 Terminated 12 enrolled Ontario Clinical Oncology Group (OCOG) Novartis Pharmaceuticals · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a single-arm, open label, two stage, phase II study of dovitinib in patients with advanced Malignant Pleural Mesothelioma (MPM). The primary purpose of this study is to evaluate the potential efficacy of dovitinib in the second- or third-line treatment of MPM using progression free survival (PFS).

Timeline

Start: 2013-03
Primary completion: 2015-06
Completion: 2015-06

Outcome

Met primary endpoint

Stopped (Enrollment): “Stage 1 accrual completed. Study did not proceed to Stage 2 accrual.”

paper PF3 was 50% (95% confidence interval 28.4% to 88.0%); although the criterion for proceeding to stage II accrual was met PMID 28213002 ↗

Publications

Laurie SA, Hao D, Leighl NB, Goffin J, Khomani A, Gupta A, Addison CL, Bane A, Seely J, Filion ML, Pond GR, Levine MN. A phase II trial of dovitinib in previously-treated advanced pleural mesothelioma: The Ontario Clinical Oncology Group. Lung Cancer. 2017 Feb;104:65-69. doi: 10.1016/j.lungcan.2016.12.004. Epub 2016 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dovitinib	Small molecule	500 mg	Oral