A Phase 2 interventional study of Irinotecan and 5-Fluorouracil (bolus) in Colorectal Cancer (CRC), sponsored by Bristol-Myers Squibb. Completed at 15 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-12.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 17 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
Drug: Irinotecan · Drug: 5-Fluorouracil (bolus) · Drug: 5-Fluorouracil (infusional) · Drug: Leucovorin calcium · Drug: CT-322
Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
Drug: Irinotecan · Drug: 5-Fluorouracil (bolus) · Drug: 5-Fluorouracil (infusional) · Drug: Leucovorin calcium · Drug: Bevacizumab · Drug: Bevacizumab Placebo (saline solution)
Solution, IV, 180 mg/m2, Q14 days, Until PD
Also known as: Camptosar
Solution, IV, 400 mg/m2, Q14 days, Until PD
Solution, IV, 2400 mg/m2, Q14 days, Until PD
Solution, IV, 400 mg/m2, Q14 days, Until PD
Solution, IV, 2 mg/kg, Q7 days, Until PD
Also known as: BMS-844203
Solutions, IV, 5 mg/kg, Q14 days, Until PD
Also known as: Avastin
Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD
Also known as: Saline Solution
Progression free survival based on tumor assessments (CT/MRI)
Time frame: Every 6 weeks until documented progressive disease, initiation fo subsequent therapy for colorectal cancer, or withdrawal of consent
Overall survival (OS), defined as the time the subject is randomized until death, in each arm
Time frame: every 12 weeks
Objective tumor response rate (ORR), defined as the proportion of randomized subjects in each arm whose best response is CR (complete response) or PR (partial response) using RECIST guidelines as determined by the site investigator
Time frame: every 6 weeks
Safety in the CT-322 plus irinotecan, 5-FU and leucovorin arm as measured by incidence of serious and non-serious adverse events, significant laboratory evaluations and significant physical examination findings in subjects
Time frame: weekly
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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