Low Dose Cyclophosphamide +/-- Nintedanib in Advanced Ovarian Cancer (METRO-BIBF)
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ClinicalTrials.gov Identifier: NCT01610869 |
Recruitment Status :
Completed
First Posted : June 4, 2012
Last Update Posted : May 29, 2019
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Sponsor:
University College, London
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
University College, London
Tracking Information | ||||
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First Submitted Date ICMJE | November 25, 2011 | |||
First Posted Date ICMJE | June 4, 2012 | |||
Last Update Posted Date | May 29, 2019 | |||
Actual Study Start Date ICMJE | August 2014 | |||
Actual Primary Completion Date | January 11, 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall survival [ Time Frame: After follow-up is complete (year 3-4 of the trial) ] To be measured in days, from the date of randomisation to the date of death.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Low Dose Cyclophosphamide +/-- Nintedanib in Advanced Ovarian Cancer | |||
Official Title ICMJE | Phase II, Randomised, Placebo Controlled, Multicentre, Feasibility Study of Low Dose (Metronomic) Cyclophosphamide With and Without Nintedanib (BIBF 1120) in Advanced Ovarian Cancer | |||
Brief Summary | The primary objective 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-relapsed advanced ovarian cancer, who have completed a minimum of two lines of previous chemotherapy and who for any reason are not suitable for further 'standard' intravenous chemotherapy treatments. | |||
Detailed Description | A randomised placebo controlled double blind multi-centre phase II trial: BIBF 1120 200mg bd plus 100mg daily of oral cyclophosphamide (experimental arm) or oral cyclophosphamide 100mg daily plus placebo (control arm). Patients will receive oral BIBF 1120 and cyclophosphamide or cyclophosphamide and placebo continuously until disease progression or unacceptable toxicity. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: BIBF 1120
Patients will receive either cyclophosphamide (100mg)and oral BIBF 1120 (200mg bd) or cyclophosphamide (100mg) and placebo.
Other Name: BIBF 1120 brand name: Nintedanib.
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Study Arms ICMJE |
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Publications * | Hall MR, Dehbi HM, Banerjee S, Lord R, Clamp A, Ledermann JA, Nicum S, Lilleywhite R, Bowen R, Michael A, Feeney A, Glasspool R, Hackshaw A, Rustin G. A phase II randomised, placebo-controlled trial of low dose (metronomic) cyclophosphamide and nintedanib (BIBF1120) in advanced ovarian, fallopian tube or primary peritoneal cancer. Gynecol Oncol. 2020 Dec;159(3):692-698. doi: 10.1016/j.ygyno.2020.09.048. Epub 2020 Oct 16. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
117 | |||
Original Estimated Enrollment ICMJE |
124 | |||
Actual Study Completion Date ICMJE | January 11, 2018 | |||
Actual Primary Completion Date | January 11, 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01610869 | |||
Other Study ID Numbers ICMJE | UCL/10/0470 2011-005814-12 ( Other Grant/Funding Number: Boehringer Ingelheim Ltd ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | University College, London | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | University College, London | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Boehringer Ingelheim | |||
Investigators ICMJE |
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PRS Account | University College, London | |||
Verification Date | October 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |