Status:
TERMINATED
Nintedanib (BIBF 1120) in Mesothelioma
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 pla...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 19 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
545 Patients enrolled
Trial Details
Trial ID
NCT01907100
Start Date
September 19 2013
End Date
August 31 2018
Last Update
March 18 2019
Active Locations (123)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
University of California San Francisco
San Francisco, California, United States, 94115
3
Rocky Mountain Cancer Centers
Littleton, Colorado, United States, 80120-4413
4
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052