NiCCC Nintedanib in Clear Cell Carcinoma A Randomised Phase II - PowerPoint PPT Presentation

NiCCC Nintedanib in Clear Cell Carcinoma A Randomised Phase II Study of BIBF 1120 versus Chemotherapy in Recurrent Clear Cell Carcinoma of the Ovary or Endometrium SGCTG/NCRI/NSGO

NiCCC Trial Design Chemotherapy Ovary: R • PLDH (40mg/m 2 day 1q28) A • Weekly Paclitaxel (80mg/m 2 day 1, 8, 15 q28) 90 pts with progressive or N • Weekly Topotecan iv (4mg/m 2 day 1, 8, 15 q28) relapsed CCC of D Endometrium: ovary within 6 O • Carboplatin (AUC 5) /Paclitaxel 175 mg/m 2 q21 months of previous platinum. M • Doxorubicin 60mg/m 2 q21 I Plus up to 30 women with S Nintedanib 200mg bd until endometrial CCC E progression Primary Endpoint: PFS Secondary Endpoints: OS, Toxicity, RR, QoL, Q-Twist

Trial Status • Study opened in the UK April 2015 – 18 centres are open – 18 patients randomised – 2 patients registered for central pathology review • GINECO due to open Nov 2016 • EORTC estimate Competent Authority submission Oct/Nov 2016 • NSGO estimate site activation in Denmark March 2017

Recruitment Graph

Recruitment by Site Site Date Activated Total no. patients Recruitment target Comment (patients/month) Beatson West of Scotland 02 Apr 2015 6 2 per year / 8 in total Cancer Centre & 1 pt transfer Belfast City Hospital 04 Mar 2016 0 1 per year Bristol Haematology and 08 Dec 2015 3 2 per year Cancer Centre Clatterbridge Cancer Centre 05 May 2016 0 5 in total 1 patient in screening The Christie, Manchester 29 Jun 2016 1 4 per year Great Western Hospital, 04 Sep 2015 1 - Pt transferred 3 per year Swindon to BWoSCC Guy’s Hospital, London 17 Feb 2016 1 2 per year East Kent Hospitals NHS Trust 09 Dec 2015 1 1.5 per year from all (3 sites in 1 Trust) sites Musgrove Park Hospital 12 May 2015 1 4 in total Ninewells Hospital, Dundee 17 Mar 2016 0 1 per year Royal Marsden Hospital 23 Jul 2015 3 5 total 2 sites in one Trust) St James’ Hospital, Leeds 23 Jul 2015 1 12 in total 1 patient in screening St Bartholomew’s Hospital, 22 Sep 2016 0 3 in total London 5 th October University College London 0 5 per year Hospital 2016 Velindre Hospital 27 Nov 2015 0 1 per year