Phase IV Panitumumab Study in Indian Subjects With Metastatic Colorectal Cancer
Status:
Recruiting
Trial end date:
2022-01-31
Target enrollment:
Participant gender:
Summary
This is an open label, multicenter, non-comparative, phase IV study of panitumumab
monotherapy in Indian subjects with previously treated, wild-type Kirsten rat sarcoma viral
oncogene homolog (KRAS) and wild-type Neuroblastoma rat sarcoma viral (v-ras) oncogene
homolog (NRAS), metastatic colorectal cancer. This study is designed to fulfil the
requirement of the Indian regulatory authority to characterize the safety and tolerability of
panitumumab when administered to Indian subjects with wild-type KRAS and wild-type NRAS
metastatic colorectal cancer. Approximately 58 Indian subjects with previously treated
wild-type KRAS and wild-type NRAS, metastatic colorectal cancer will be enrolled in order to
achieve the target enrollment of 50 evaluable subjects who have received at least one dose of
panitumumab. Subjects will receive panitumumab 6 milligram/kilogram (mg/kg) intravenously
every 14 days until disease progression, intolerability, withdrawal of consent, or death. All
subjects will be followed at 4 weeks and 8 weeks after the last administration of
panitumumab, unless the treatment was discontinued due to withdrawal of consent or death of
the subject.