Transcription of Description Objectives Primary Objectives - PBTC
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Description Objectives Primary Objectives - PBTC
PBTC-025B Version Date: 5/1/2009 Confidential Page 1 of 6 PBTC-025B - A Phase II Clinical Trial Evaluating the Efficacy and Safety of GDC-0449 in Adults with Recurrent or Refractory Medulloblastoma Description This is a multicenter, phase II trial for adults with recurrent or refractory medulloblastoma to describe the efficacy, response and toxicities of the drug in patients with recurrent or refractory medulloblastoma. Objectives Primary Objectives To estimate the efficacy of GDC-0449 treatment for adult patients with recurrent or refractory medulloblastoma, as measured by the objective response rates for patients without (Stratum A) and with (Stratum B) evidence of activation of Sonic Hedgehog (SHH) signaling pathway tumors. Secondary Objectives To assess the safety and tolerability of GDC-0449 administered on a once daily schedule.
PBTC-025B v1.0 Version Date: 5/1/2009 Confidential Page 1 of 6 PBTC-025B - A Phase II Clinical Trial Evaluating the Efficacy and Safety of GDC-
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