Nintedanib (BIBF 1120) in Mesothelioma

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Mesothelioma

In brief

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.

Key facts

Study ID

NCT01907100

Run by

Boehringer Ingelheim

People needed

545

Starts

2013-09-19

Expected to finish

2018-08-31

Last updated by the study team

2019-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California San Francisco — San Francisco, California, United States
• Rocky Mountain Cancer Centers — Littleton, Colorado, United States
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Greenville Health System — Greenville, South Carolina, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Texas Oncology - McAllen — McAllen, Texas, United States
• Texas Oncology-San Antonio Northeast — San Antonio, Texas, United States
• Cancer Care Northwest Centers, PS — Spokane Valley, Washington, United States
• Sanatorio Güemes — Ciudad Autónoma de Bs As, Argentina
• Instituto Medico Especializado Alexander Fleming — Ciudad Autónoma de Bs As, Argentina
• Clínica Universitaria Reina Fabiola — Córdoba, Argentina
• Northern Cancer Institute — St Leonards, New South Wales, Australia
• Calvary Mater Newcastle Hospital — Waratah, New South Wales, Australia
• The Prince Charles Hospital — Chermside, Queensland, Australia
• Mater Cancer Care Centre — South Brisbane, Queensland, Australia
• Box Hill Hospital — Box Hill, Victoria, Australia
• Peninsula Haematology & Oncology — Frankston, Victoria, Australia
• Austin Health — Heidelberg, Victoria, Australia
• Border Onclogy Research — Wodonga, Victoria, Australia
• Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
• Perth Oncology — Perth, Western Australia, Australia
• LKH Leoben — Leoben, Austria
• AKH - Medical University of Vienna — Vienna, Austria
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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