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Brief Title: Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma
Official Title: A Phase 1b, Safety, PK, and Efficacy, Multicenter, Dose-Escalating Study of Imprime PGG in Combination With Cetuximab With and Without Irinotecan Therapy in Patients With Recurrent/Progressive Colorectal Carcinoma Following Treatment With a 5-FU Regimen.
Study ID: NCT00545545
Brief Summary: Phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of Imprime PGG™ Injection dosed in combination with Cetuximab and concomitant irinotecan therapy. Enrolled patients will have a confirmed diagnosis of recurrent or progressive colorectal carcinoma following treatment with a 5-fluorouracil-containing regimen.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medical City, Makati City, , Philippines
Philippine General Hospital, Manila, , Philippines
Name: Ma. Belen Tamayo, MD
Affiliation: The Medical City Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Gerardo Cornelio, MD, FPCP/FPS
Affiliation: Philippines General Hospital
Role: PRINCIPAL_INVESTIGATOR