GANNET53: Ganetespib in Metastatic, p53-mutant, Platinum-resistant Ovarian Cancer
Status:
Terminated
Trial end date:
2017-12-04
Target enrollment:
Participant gender:
Summary
Epithelial ovarian cancer (EOC) is the most lethal gynaecological malignancy causing 41900
deaths annually in Europe. The predominance of aggressive Type II tumours, which are
characterised by a high frequency of p53 mutations, and primary or acquired resistance to
platinum-based chemotherapy profoundly contribute to the high mortality rate. With current
standard therapy the median overall survival of metastatic platinum-resistant (Pt-R) ovarian
cancer patients is only 14 month. There is a pressing need for more effective, innovative
treatment strategies to particularly improve survival in this subgroup of EOC patients. This
is a drug strategy targeting a central driver of tumour aggressiveness and metastatic
ability, namely mutant p53, via an innovative new Hsp90 (heat shock protein 90) inhibition
mechanism. The most advanced, second-generation Hsp90 inhibitor will be used, Ganetespib. The
first part (Phase I) of the GANNET53 trial will test the safety of Ganetespib in a new
combination with standard chemotherapy (Paclitaxel weekly) in Pt-R EOC patients. The second
part (randomised Phase II) will examine the efficacy of Ganetespib in combination with
standard chemotherapy versus standard chemotherapy alone in EOC patients with Pt-R tumours.