Study of Gemcitabine, Carboplatin and VELIPARIB (ABT-888) in Refractory Testicular Germ Cell Cancer
Status:
Completed
Trial end date:
2021-02-15
Target enrollment:
Participant gender:
Summary
This is a proof-of-concept study to define efficacy of gemcitabine, carboplatin and VELIPARIB
(ABT-888) in patients with refractory germ cell tumors (GCTs). PARP proteins are involved in
base excision repair (BER), one of the major DNA repair system in cells and PARP is
overexpressed in testicular GCTs (TGCTs) compared to normal testis and data suggest that PARP
overexpression is early event in TGCTs development. Patients with low PARP expression in
primary tumour had non-significantly better OS compared to patients with high PARP expression
(5-year OS 89.2% vs 78.7%; HR=0.50, 95% CI 0.21 to 1.17, p=0.12). The aim of this study is to
evaluate PARP inhibitor VELIPARIB in combination with gemcitabine, carboplatin in patients
with refractory germ cell tumors (GCTs).