Return to Clinical Trials Search Results
A Phase III Study of BBI-608 in Combination With 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC).
PRIMARY OBJECTIVE OF THE STUDY:
To compare overall survival (OS) of patients with metastatic (Stage IV) pretreated CRC treated with BBI-608 plus biweekly FOLFIRI with or without bevacizumab versus biweekly FOLFIRI with or without bevacizumab.
SECONDARY OBJECTIVES:
To compare OS in patients treated with BBI-608 plus biweekly FOLFIRI with or without bevacizumab versus biweekly FOLFIRI with or without bevacizumab in biomarker positive CRC patients.
To compare PFS in patients treated with BBI-608 plus biweekly FOLFIRI with or without bevacizumab versus biweekly FOLFIRI with or without bevacizumab.
To compare PFS in patients treated with BBI-608 plus biweekly FOLFIRI with or without bevacizumab versus biweekly FOLFIRI with or without bevacizumab in biomarker positive CRC patients.
To compare ORR in patients treated with BBI-608 plus biweekly FOLFIRI with or without bevacizumab versus biweekly FOLFIRI with or without bevacizumab.
To compare DCR in patients treated with BBI-608 plus biweekly FOLFIRI with or without bevacizumab versus biweekly FOLFIRI with or without bevacizumab.
To compare ORR and DCR in patients treated with BBI-608 plus biweekly FOLFIRI with or without bevacizumab versus biweekly FOLFIRI with or without bevacizumab in biomarker positive CRC patients.
To evaluate the safety profile of BBI-608 administered daily plus biweekly FOLFIRI with or without bevacizumab with safety assessed according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0.
To compare the Quality of Life (QoL), as measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30), in patients with pretreated metastatic CRC treated with BBI-608 plus standard bi-weekly FOLFIRI with or without bevacizumab versus standard bi-weekly FOLFIRI with or without bevacizumab.
PRIMARY OBJECTIVE OF THE STUDY:
To compare overall survival (OS) of patients with metastatic (Stage IV) pretreated CRC treated with BBI-608 plus biweekly FOLFIRI with or without bevacizumab versus biweekly FOLFIRI with or without bevacizumab.
SECONDARY OBJECTIVES:
To compare OS in patients treated with BBI-608 plus biweekly FOLFIRI with or without bevacizumab versus biweekly FOLFIRI with or without bevacizumab in biomarker positive CRC patients.
To compare PFS in patients treated with BBI-608 plus biweekly FOLFIRI with or without bevacizumab versus biweekly FOLFIRI with or without bevacizumab.
To compare PFS in patients treated with BBI-608 plus biweekly FOLFIRI with or without bevacizumab versus biweekly FOLFIRI with or without bevacizumab in biomarker positive CRC patients.
To compare ORR in patients treated with BBI-608 plus biweekly FOLFIRI with or without bevacizumab versus biweekly FOLFIRI with or without bevacizumab.
To compare DCR in patients treated with BBI-608 plus biweekly FOLFIRI with or without bevacizumab versus biweekly FOLFIRI with or without bevacizumab.
To compare ORR and DCR in patients treated with BBI-608 plus biweekly FOLFIRI with or without bevacizumab versus biweekly FOLFIRI with or without bevacizumab in biomarker positive CRC patients.
To evaluate the safety profile of BBI-608 administered daily plus biweekly FOLFIRI with or without bevacizumab with safety assessed according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0.
To compare the Quality of Life (QoL), as measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30), in patients with pretreated metastatic CRC treated with BBI-608 plus standard bi-weekly FOLFIRI with or without bevacizumab versus standard bi-weekly FOLFIRI with or without bevacizumab.
Recruitment Status
Past Studies