CLINICAL TRIAL SUMMARY

MDACC Study No:2009-0990 (clinicaltrials.gov NCT No: NCT01075048)
Title:A Randomized, Placebo-Controlled, Phase I/2 Study of ARQ 197 in Combination with Irinotecan and Cetuximab in Subjects with Metastatic Colorectal Cancer with Wild-Type KRAS Who Have Received Front-Line Systemic Therapy (ARQ 197-A-U252)
Principal Investigator:Cathy Eng
Treatment Agent:ARQ-197; Cetuximab; Irinotecan
Study Status:Terminated
Study Description:The goal of this clinical research study is to find the highest tolerable dose
of the combination of ARQ 197, Camptosar® (irinotecan), and ERBITUX®
(cetuximab) that can be given to patients with metastatic colorectal cancer.
The safety of this drug combination will also be studied.

Optional Procedures: You are being asked to allow blood left over from a test
performed on this study to be stored in a research blood bank for use in future
research related to cancer.

Hide details for General InformationGeneral Information

Disease Group:Colorectum
Phase of Study:Phase I/Phase II
Treatment Agents:ARQ-197
Cetuximab
Irinotecan
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:Hospitalization is not required
Supported By:Daiichi Sankyo Pharma Development
Return Visit:Every 2 weeks.
Home Care:ARQ 197 is administered orally and patients may self-administer it.


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Cathy Eng
Dept:Gastrointestinal Medical Oncology
For Clinical Trial Enrollment:713-792-2828
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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