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

▶

Dec 05, 2023 502 likes •588 views

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

SLIDE 1

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

NiCCC Nintedanib in Clear Cell Carcinoma

SLIDE 2

NiCCC Trial Design

90 pts with progressive or relapsed CCC of

vary within 6

months of previous platinum. Plus up to 30 women with endometrial CCC

R A N D O M I S E

Chemotherapy Ovary:

PLDH (40mg/m2 day 1q28)
Weekly Paclitaxel (80mg/m2 day 1, 8, 15 q28)
Weekly Topotecan iv (4mg/m2 day 1, 8, 15 q28)

Endometrium:

Carboplatin (AUC 5) /Paclitaxel 175 mg/m2 q21
Doxorubicin 60mg/m2 q21

Nintedanib 200mg bd until progression Primary Endpoint: PFS Secondary Endpoints: OS, Toxicity, RR, QoL, Q-Twist

SLIDE 3

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

SLIDE 4

Recruitment Graph

SLIDE 5

Recruitment by Site

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