Nintedanib (BIBF 1120) in Mesothelioma

• Status: Terminated
• Trial end date: 2018-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Cisplatin; Nintedanib; Pemetrexed

Criteria

Inclusion criteria:

• Histologically confirmed malignant pleural mesothelioma (MPM) (Epithelioid or biphasic subtype for Phase II patients; epithelioid subtype only for Phase III patients)

• Life expectancy of at least 3 months in the opinion of the investigator

• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

• Measurable disease according to modified RECIST (Response Evaluation Criteria In Solid Tumours) criteria

Exclusion criteria:

• Previous systemic chemotherapy for MPM

• Prior treatment with nintedanib or any other prior line of therapy

• Phase II patients with sarcomatoid subtype MPM or Phase III patients with biphasic or sarcomatoid subtype MPM

• Patients with symptomatic neuropathy

• Radiotherapy (except extremities) within 3 months prior to baseline imaging

• Active brain metastases (e.g. stable for < 4 weeks)

• Radiographic evidence of cavitary or necrotic tumours or local invasion of major blood vessels by MPM

• Significant cardiovascular diseases

• Inadequate hematologic, renal, or hepatic function