drugset / Trial / NCT00614393

Study of Dalotuzumab (MK-0646) in Combination With Cetuximab and Irinotecan in Metastatic Colorectal Cancer (MK-0646-004)

Phase 2 Completed 558 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will compare the safety and efficacy of dalotuzumab (MK-0646) in combination with cetuximab and irinotecan in treating participants with wild type KRAS (wtKRAS) metastatic colorectal cancer (CRC) compared to cetuximab and irinotecan alone. The primary study hypothesis is that administration of dalotuzumab in combination with cetuximab and irinotecan to participants with metastatic CRC expressing the wtKRAS genotype improves Overall Survival OR Progression-free Survival compared to participants treated with cetuximab and irinotecan alone.

Timeline

Start: 2007-12-24
Primary completion: 2010-06-01
Completion: 2012-03-07

Outcome

Missed primary endpoint

registry Dalotuzumab 10 mg/kg Q1W (DB) vs Placebo + Cetuximab + Irinotecan (DB); p = 0.06; Hazard Ratio (HR) 1.41 (95% CI 0.99 to 2.00) NCT00614393 ↗

registry Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB) vs Placebo + Cetuximab + Irinotecan (DB); p = 0.18; Hazard Ratio (HR) 1.26 (95% CI 0.89 to 1.79) NCT00614393 ↗

registry Dalotuzumab 10 mg/kg Q1W (DB) vs Placebo + Cetuximab + Irinotecan (DB); p = 0.07; Hazard Ratio (HR) 1.33 (95% CI 0.98 to 1.83) NCT00614393 ↗

registry Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB) vs Placebo + Cetuximab + Irinotecan (DB); p = 0.44; Hazard Ratio (HR) 1.13 (95% CI 0.83 to 1.55) NCT00614393 ↗

Publications

Background Sclafani F, Kim TY, Cunningham D, Kim TW, Tabernero J, Schmoll HJ, Roh JK, Kim SY, Park YS, Guren TK, Hawkes E, Clarke SJ, Ferry D, Frodin JE, Ayers M, Nebozhyn M, Peckitt C, Loboda A, Mauro DJ, Watkins DJ. A Randomized Phase II/III Study of Dalotuzumab in Combination With Cetuximab and Irinotecan in Chemorefractory, KRAS Wild-Type, Metastatic Colorectal Cancer. J Natl Cancer Inst. 2015 Sep 23;107(12):djv258. doi: 10.1093/jnci/djv258. Print 2015 Dec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	dalotuzumab	Monoclonal antibody	7.5 mg/kg	Intravenous
Subject	dalotuzumab	Monoclonal antibody	10 mg/kg	Intravenous
Background	Cetuximab	Monoclonal antibody	250 mg/m2	Intravenous
Background	Irinotecan	Small molecule	—	Intravenous