766TiP - CARD: A randomized phase 4 trial comparing cabazitaxel and an androgen receptor (AR)-targeted agent in men with metastatic castration-resistant pro...

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Cytotoxic agents
Prostate Cancer
Therapy
Biological therapy
Presenter Ronald de Wit
Citation Annals of Oncology (2016) 27 (6): 243-265. 10.1093/annonc/mdw372
Authors R. de Wit1, K. Fizazi2, E. Efstathiou3, R. Dittamore4, S. Hitier5, K. Pantel6, C. Sternberg7, B.F. Tombal8, C. Wülfing9, J. de Bono10
  • 1Medical Oncology, Erasmus University Medical Center, 3075EA - Rotterdam/NL
  • 2Department Of Cancer Medicine, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 3Gu Medical Oncology  , md anderson cancer center  , 77030   - Houston/US
  • 4Translational Research, Epic Sciences Inc., 92121 - San Diego/US
  • 575, Sanofi, 75008 Paris - Paris/FR
  • 6Tumor Biology, UKE Universitätsklinikum Hamburg-Eppendorf KMTZ, 20246 - Hamburg/DE
  • 7Oncology, San Camillo–Forlanini Hospital, 00152 - Rome/IT
  • 8Urology, Cliniques Universitaires St. Luc, 12000 - Brussels/BE
  • 9Urology, Asklepios Klinik Altona, 22763 - Hamburg/DE
  • 10Oncology, Royal Marsden Hospital NHS Foundation Trust, SW3 6JJ - London/GB

Abstract

Background

mCRPC is highly heterogeneous with coexistence of AR-dependent and AR-independent tumor clones. New AR-targeted agents (abiraterone acetate, enzalutamide) and taxanes (docetaxel (DOC), cabazitaxel - specifically developed to overcome DOC resistance) are the backbone of mCRPC therapy. The rising concern of cross-resistance between mCRPC therapies and the evidence that some patients may not respond to all available drugs have increased the complexity of managing mCRPC. There is thus a need to design trials helping to define the optimal sequence of therapies to optimize patient outcomes.

Trial design

CARD is a randomized phase 4 trial involving 79 sites in 12 European countries. A total of 324 patients with mCRPC previously treated with DOC and who failed a prior AR-targeted agent (abiraterone acetate or enzalutamide, either before or after DOC) within 12 months of AR-targeted treatment initiation will be randomized (1:1) to receive cabazitaxel (25mg/m2 every 3 weeks plus daily prednisone and prophylactic G-CSF) or the alternative AR-targeted agent until radiographic progression, unacceptable toxicity or patient's request. Randomization will be stratified by ECOG performance status (0-1 vs. 2), time to progression with prior AR-targeted agent (

Clinical trial identification

NCT02485691

Legal entity responsible for the study

Sanofi

Funding

Sanofi

Disclosure

R. de Wit: Research grant from Sanofi International coordinator of CARD study Consulting fees from Sanofi.

R. de Wit: Research grant from Sanofi. Consulting fee from Sanofi CARD investigator and Steering committee member.

K. Fizazi: Paid advisor at Sanofi advisory boards Investigator and steering committee member for CARD study.

E. Efstathiou: Research grant from Sanofi. Paid advisor at Sanof advisory boards. Investigator and steering Committee member of CARD study.

R. Dittamore: Employee of Epic Sciences, Inc., La Jolla, USA.

S. Hitier: CARD statistician - Employee of Sanofi.

K. Pantel: Member of CARD translational steering committee.

C. Sternberg: Investigator and steering committee member of CARD study. Consulting fee from Sanofi

B. Tombal: Paid advisor by Sanofi Investigator and Steering Committee member of CARD study.

C. Wülfing: Investigator and steering committee member of CARD study.

J. de Bono: Johann de Bono served on Sanofi advisory boards as a paid advisor. He is also investigator and member of CARD Steering committee.