Adult Glioblastoma Clinical Trial
Official title:
A Phase II and Pharmacodynamic Trial of RO4929097 for Patients With Recurrent/Progressive Glioblastoma
This phase II trial is studying how well gamma-secretase/Notch signalling pathway inhibitor RO4929097 works in treating patients with recurrent or progressive glioblastoma. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. 6-month progression-free survival (PFS6). (Group A) II. Efficiency of neurosphere
generation after pretreatment with RO4929097 (gamma-secretase/Notch signalling pathway
inhibitor RO4929097). (Group B)
SECONDARY OBJECTIVES:
I. Radiographic response rate. (Group A) II. Toxicities associated with this regimen. (Group
A) III. Overall survival. (Group A) IV. Expression levels of Notch pathway components and
downstream targets. (Group B) V. Tumor propagation. An extension of lifespan by 50% in tumor
bearing mice (mice bearing fresh tumor tissue). (Group B) VI. Patient event-free survival in
correlation with expression levels of Notch pathway components and downstream targets.
VII. 6-month progression-free survival (PFS6). VIII. Toxicities associated with this
regimen. IX. Overall survival.
OUTLINE: Patients are assigned to 1 of 2 treatment groups.
GROUP A: Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097
orally (PO) once daily (QD) on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.
GROUP B (surgical resection indicated): Patients receive gamma-secretase/Notch signalling
pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on
day 0. Within 30 days after surgical resection, patients receive gamma-secretase/Notch
signalling pathway inhibitor RO4929097 as in Group A.
After completion of study treatment, patients are followed up every 2 months.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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