NCT01610869

Low Dose Cyclophosphamide +/-- Nintedanib in Advanced Ovarian Cancer

Phase II, Randomised, Placebo Controlled, Multicentre, Feasibility Study of Low Dose (Metronomic) Cyclophosphamide With and Without Nintedanib (BIBF 1120) in Advanced Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
DRUG	BIBF 1120	Patients will receive either cyclophosphamide (100mg)and oral BIBF 1120 (200mg bd) or cyclophosphamide (100mg) and placebo.

Timeline

• Start date: 2014-08-01
• Primary completion: 2018-01-11
• Completion: 2018-01-11
• First posted: 2012-06-04
• Last updated: 2019-05-29

Locations

16 sites across 1 country: United Kingdom