Spots Global Cancer Trial Database for FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer
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Trial Identification
Brief Title: FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer
Official Title: An Open-Label, Multicenter, Randomized Phase Ib/II Study of FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer
Study ID: NCT01133990
Conditions
Study Description
Brief Summary: The purpose of the Phase Ib portion is to find out the highest dose of study drug that can safely be given when tested in a small group of subjects. The purpose of the Phase II portion is to find out how safe the study drug is when taken at the highest dose in a larger group of subjects.
Detailed Description: The primary purpose for Phase 1b: to determine the maximum tolerated dose (MTD) of E7820 recommended for Phase 2 when administered in combination with the FOLFIRI regimen (irinotecan, leucovorin, and 5-fluorouracil \[5-FU\]) in participants with locally advanced or metastatic colorectal cancer (mCRC) who have failed first-line therapy. Phase 2: to evaluate the safety and tolerability of E7820 administered in combination with the FOLFIRI regimen, compared with FOLFIRI alone and FOLFIRI plus bevacizumab, in patients with locally advanced or mCRC who have failed first-line therapy.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rocky Mountain Cancer Center - Midtown, Denver, Colorado, United States
Summit Medical Group, Berkeley Heights, New Jersey, United States
Hematology Oncology Associates SJ P.A., Mount Holly, New Jersey, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Northwest Medical Specialties, PLLC, Tacoma, Washington, United States
North Coast Cancer Institute, Coffs Harbour, New South Wales, Australia
Sydney Haematology & Oncology Clinic, Hornsby, New South Wales, Australia
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Royal Hobart Hospital, Hobart, South Australia, Australia
Queen Elizabeth Hospital, Woodville South, South Australia, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
The Austin Hospital, Epping, Victoria, Australia
Newcastle Private Hospital, Merewether, , Australia
Jawaharlal Nehru Cancer Hospital and Research Centre, Bhopal, Madhya Pradesh, India
Searoc Cancer Hosptial, Jaipur, Rajasthan, India
Gujarat Cancer & Research Institute, Ahmedabad, , India
Kidwai Institute of Oncology, Bangalore, , India
M. S. Ramaiah Memorial Hospital, Bangalore, , India
Subodh Mitra Cancer Hospital and Research centre, Kolkata, , India
Shatabdi Hospital, Nashik, , India
Deenanath Mangeshkar Hospital and Research Center, Pune, , India
Noble Hospital, Pune, , India
Christian Medical College, Vellore, , India
CCH #2 n.a. N. A. Semashko of LLC "Russian Railways", Moscow, , Russian Federation
City Mariinskaya Hospital, St Petersburg, , Russian Federation
Scientific Research Oncology Institute named after N.N. Petr, St Petersburg, , Russian Federation
Yaroslav Regional Clinical Oncology Hospital, Yaroslav, , Russian Federation
Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU, Dnipropetrovsk, , Ukraine
Donetsk Regional Anticancer Centre, Donetsk, , Ukraine
City Clinical Hospital #2, Kharkiv, , Ukraine
The St.Inst. "S.P.Grigoriev Med. Rad.Inst. of AMS of Ukr.", Kharkiv, , Ukraine
Uzhgorod Centr.City Cl.Hosp.,City Onc.Center, UNMU,Fac.of PG, Uzhgorod, , Ukraine
Contact Details
Name: Harish Dave
Affiliation: Quintiles, Inc.
Role: STUDY_DIRECTOR
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