A Study of BBI608 in Adult Patients With Advanced Colorectal Cancer
This is an open label study of BBI608 in combination with cetuximab, panitumumab or capecitabine in patients with advanced colorectal cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Clinical Study of BBI608 in Adult Patients With Advanced Colorectal Cancer|
- Disease Control Rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Assessment of Disease Control Rate, defined as the proportion of patients with a documented complete response, partial response and stable disease based on RECIST, in patients with advanced colorectal cancer given BBI608 in combination with cetuximab, panitumumab or capecitabine
- Overall Survival [ Time Frame: From date of randomization until the date of death, assessed up to 100 months ] [ Designated as safety issue: No ]Assessment of Overall Survival in patients with advanced colorectal cancer given BBI608 in combination with cetuximab, panitumumab or capecitabine
- Progression Free Survival [ Time Frame: From date of randomization until the date of first documented progression or death, whichever comes first, assessed up to 100 months ] [ Designated as safety issue: No ]Assessment of Progression Free Survival in patients with advanced colorectal cancer given BBI608 in combination with cetuximab, panitumumab or capecitabine by performing tumor assessments every 8 weeks.
- Safety [ Time Frame: Adverse events will be assessed at baseline, while the participant is taking BBI608, and for 30 days after stopping therapy. The average length of this duration is expected to be approximately 4 months. ] [ Designated as safety issue: Yes ]Assessment of safety of BBI608 given in combination with cetuximab, panitumumab or capecitabine to patients with advanced colorectal cancer by reporting of adverse events and serious adverse events
- Pharmacokinetics [ Time Frame: On Day 5 and Day 26 in the cetuximab combination arm; on Day 8 and 22 in the panitumumab combination arm; and on Day 8 and 21 in the capecitabine combination arm ] [ Designated as safety issue: No ]Observe the area under the plasma concentration versus time curve of BBI608 in combination with cetuximab, BBI608 in combination with panitumumab, and BBI608 in combination with capecitabine
- Pharmacodynamics [ Time Frame: At baseline and at 4 hours after administration of BBI608 morning dose on Day 8 ] [ Designated as safety issue: No ]Pharmacodynamic assessments to analyze biomarkers in tumor tissues will be performed in patients when tumor biopsy with a minimally invasive procedure is deemed possible by Investigator.
|Study Start Date:||March 2012|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: BBI608 in combination with cetuximab||
BBI608 is administered at 500 mg po bid continuously.Drug: Cetuximab
Cetuximab will be administered IV on day 5 at 400 mg/m2 intravenous infusion over 120 minutes as the initial dose, then weekly at 250mg/m2 over 60-minutes at subsequent cycles.
Other Name: Erbitux
|Experimental: BBI608 in combination with panitumumab||
BBI608 is administered at 500 mg po bid continuously.Drug: Panitumumab
Panitumumab will be administered IV on day 8 and 22 of each 28 day cycle at 6 mg/kg over 60 minutes.
Other Name: Vectibix
|Experimental: BBI608 in combination with capecitabine||
BBI608 is administered at 500 mg po bid continuously.Drug: Capecitabine
Capecitabine will be administered orally at 1000 mg/m2 bid daily on days 8-21 every three weeks.
Other Name: Xeloda
This is an open label, multi-center, Phase II study of BBI608 administered in combination with either cetuximab, or panitumumab, or capecitabine. A cycle will consist of daily and continuous oral administration of BBI608 for four weeks in combination with either cetuximab, or panitumumab, or capecitabine.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776307
|Contact: Boston Biomedical||617-674-6800|
|United States, Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Mayo Clinic Clinical Trials Office 507-538-7623|
|Principal Investigator: Joleen M Hubbard, MD|
|United States, Ohio|
|The Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Sanaa Tahiri 614-293-5894 Sanaa.Tahiri@osumc.edu|
|Principal Investigator: Ciombor Kristen, MD|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Melissa Kirsch, RN 215-349-5785 Melissa.firstname.lastname@example.org|
|Principal Investigator: Peter O'Dwyer, MD|
|United States, South Carolina|
|Institute for Translational Oncology Research, Greenville Hospital System||Recruiting|
|Greenville, South Carolina, United States, 29605|
|Contact: Jan Kueber, RN 864-455-3600 email@example.com|
|Principal Investigator: William J. Edenfield, MD|
|United States, Texas|
|US Oncology Research||Recruiting|
|The Woodlands, Texas, United States, 77380|
|Contact: Lee Wiliams 281-863-6660|
|Principal Investigator: Tim G Larson, MD|
|Principal Investigator:||William J. Edenfield, MD||Institute for Translational Oncology Research, Greenville Hospital System|