NCT02568449

Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent

A Phase II Trial of BIBF 1120 (Nintedanib) in Recurrent Malignant Pleural Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well nintedanib works in treating patients with malignant pleural mesothelioma that has come back. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To assess the 4-month progression-free survival (PFS) in patients with recurrent, unresectable malignant pleural mesothelioma (MAM) treated with nintedanib. SECONDARY OBJECTIVES: I. To assess response rate (confirmed and unconfirmed, complete and partial responses) and disease control rate (response or stable disease) in the subset of patients with measurable disease by both RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria and Modified RECIST criteria for pleural tumors. II. To assess overall survival. III. To evaluate the frequency and severity of toxicities associated with this treatment regimen. IV. To collect tissue samples for future correlative studies related to overall study objectives. OUTLINE: Patients receive nintedanib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.

Conditions

• Recurrent Pleural Malignant Mesothelioma
• Stage IV Pleural Mesothelioma

Interventions

Type	Name	Description
DRUG	Nintedanib	Given PO

Timeline

• Start date: 2016-03-15
• Primary completion: 2017-01-01
• Completion: 2018-06-26
• First posted: 2015-10-05
• Last updated: 2021-12-09
• Results posted: 2021-12-09

Locations

3 sites across 1 country: United States