Trial Details
Trial status:
Recruitment start date:
Boehringer Ingelheim Pharmaceuticals
Chief Investigator:
Dr Marcia Hall
Recruitment target:
EudraCT number:
Contact details:
Lay summary:
Phase II, randomised, placebo controlled, multicentre, feasibility study of low dose (metronomic) cyclophosphamide with or without nintedanib (BIBF1120) in advanced ovarian cancer (METRO–BIBF)
Design: METRO-BIBF is a phase II, randomised, placebo-controlled, multi-centre, feasibility study of low dose (metronomic) cyclophosphamide with and without nintedanib (BIBF 1120) in advanced ovarian cancer.
Treatment: All patients will be randomised to receive oral nintedanib or placebo 150 mg twice daily and cyclophosphamide 100 mg daily continuously until disease progression, death or unacceptable toxicity. 
Key inclusion/exclusion criteria: Patients with advanced ovarian cancer who have received 2 or more lines of chemotherapy for advanced ovarian cancer, are platinum resistant or intolerant and or not suitable for any further intravenous chemotherapy, with ECOG performance status 0 to 2 and life expectancy of more than 6 weeks. Patients must not have carcinosarcomas or malignant tumour of non-epithelial origin, active brain metastases, clinically relevant therapy-related toxicity from previous chemotherapy and radiotherapy.
Duration of recruitment: The actual recruitment was 2 years (anticipated 1.5 years).
The aim of the study is to explore the efficacy and safety of an all oral combination of BIBF 1120 (an inhibitor of angiogenic signalling) and metronomic cyclophosphamide in patients with multiply-replased advanced ovarian cancer, who have completed minimum of two lines of previous chemotherapy and who for any reason are not suitable further ‘standard’ intravenous chemotherapy treatments.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
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