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A Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) for Reduction of Oral Mucositis in Subjects with St...

Update Il y a 4 ans
Reference: EUCTR2004-005007-14

A Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) for Reduction of Oral Mucositis in Subjects with Stage 2B or 3 Locally Advanced, Colon Cancer Receiving 5-FU and Leucovorin as Adjuvant Therapy

Woman and Man

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Extract

To evaluate the effect of palifermin on the incidence of Grade ≥ 2 OM induced by adjuvant chemotherapy in subjects with stage 2B and 3 locally advanced colon cancer in cycle 1, when administered as a single dose of 120 μg/kg three days prior to each 4-week cycle of 5-FU and leucovorin

Inclusion criteria

  • Oral mucositis (OM) associated with multi-cycle chemotherapy with fluoropyrimidine containing regimens

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