Nintedanib (BIBF 1120) in Mesothelioma

Boehringer Ingelheim

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Mesothelioma

Treatments: Drug: Nintedanib; Drug: Placebo; Drug: Cisplatin; Drug: Pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT01907100

1199.93

2012-005201-48 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 545 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

545 participants in 2 patient groups, including a placebo group

Placebo + pemetrexed/cisplatin

Placebo Comparator group

Description:

Placebo controlled arm

Treatment:

Drug: Placebo

Drug: Pemetrexed

Drug: Pemetrexed

Drug: Cisplatin

Drug: Cisplatin

Nintedanib 200mg + pemetrexed/cisplatin

Experimental group

Description:

Experimental arm

Treatment:

Drug: Pemetrexed

Drug: Pemetrexed

Drug: Nintedanib

Drug: Cisplatin

Drug: Cisplatin