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Spots Global Cancer Trial Database for A Study of Ramucirumab or Icrucumab in Colorectal Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: A Study of Ramucirumab or Icrucumab in Colorectal Cancer

Official Title: An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of 5 FU/FA and Oxaliplatin (Modified FOLFOX 6) in Combination With Ramucirumab or IMC-18F1 or Without Investigational Therapy as Second Line Therapy in Patients With Metastatic Colorectal Cancer Following Disease Progression on First Line Irinotecan-based Therapy

Study ID: NCT01111604

Study Description

Brief Summary: The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.

Detailed Description: The purpose of this study is to evaluate the progression-free survival (PFS) in participants with metastatic colorectal cancer when treated with 1 of 3 modified FOLFOX-6 (folinic acid \[FA\] + fluorouracil \[5-FU\] + oxaliplatin \[mFOLFOX-6\])-based regimens, as second-line therapy. During 2010, there has been an identified shortage of injectable folinic acid (FA) in the United States. Levo-folinic acid (LFA) will be allowed as a substitute for FA in the mFOLFOX-6 chemotherapy regimen in circumstances in which FA is not available, to facilitate continuity of participant care.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

ImClone Investigational Site, Cincinnati, Ohio, United States

ImClone Investigational Site, Columbia, South Carolina, United States

ImClone Investigational Site, Nashville, Tennessee, United States

ImClone Investigational Site, Calgary, Alberta, Canada

ImClone Investigational Site, Edmonton, Alberta, Canada

ImClone Investigational Site, Kelowna, British Columbia, Canada

ImClone Investigational Site, Surrey, British Columbia, Canada

ImClone Investigational Site, Vancouver, British Columbia, Canada

ImClone Investigational Site, Halifax, Nova Scotia, Canada

ImClone Investigational Site, Hamilton, Ontario, Canada

ImClone Investigational Site, London, Ontario, Canada

ImClone Investigational Site, Mississauga, Ontario, Canada

ImClone Investigational Site, Oshawa, Ontario, Canada

ImClone Investigational Site, Ottawa, Ontario, Canada

ImClone Investigational Site, Toronto, Ontario, Canada

ImClone Investigational Site, Windsor, Ontario, Canada

ImClone Investigational Site, Montreal, Quebec, Canada

Contact Details

Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Affiliation: Eli Lilly and Company

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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