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Trial Details
Trial status:
Closed
Recruitment start date:
18/08/2014
Funder:
Boehringer Ingelheim Pharmaceuticals
Sponsor:
UCL
Chief Investigator:
Dr Marcia Hall
Recruitment target:
124
EudraCT number:
2011-005814-12
Contact details:
ctc.METROBIBF@ucl.ac.uk
Lay summary:
METRO-BIBF
Phase II, randomised, placebo controlled, multicentre, feasibility study of low dose (metronomic) cyclophosphamide with or without nintedanib (BIBF1120) in advanced ovarian cancer (METRO–BIBF)
Description
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).
Aim
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
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
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London
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Email:
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Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
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