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Phase Ib/II Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme

2014-10-01 16:53:22 | BioPortfolio

Summary

This is a multi-center, phase Ib/ II study (two parts) with patients that have recurrent glioblastoma multiforme. The first part (phase Ib) will investigate the maximum tolerated dose/Recommended phase ll dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin or buparlisib once daily in combination with every-six-week lomustine (CCNU) using a Bayesian model. Once MTD/ RP2D is established in either of the 2 arms, the corresponding phase II portion of the study will start. Phase II will assess the treatment effect of buparlisib in combination with carboplatin in terms of Progression Free Survival (PFS) and will compare the treatment effect of buparlisib with lomustine versus lomustine plus placebo in terms of PFS.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Recurrent Glioblastoma Multiforme (rGBM)

Intervention

buparlisib, carboplatin, lomustine, placebo

Location

Ironwood Cancer and Research Centers SC
Chandler
Arizona
United States
85224

Status

Recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-10-01T16:53:22-0400

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Medical and Biotech [MESH] Definitions

Benign and malignant central nervous system neoplasms derived from glial cells (i.e., astrocytes, oligodendrocytes, and ependymocytes). Astrocytes may give rise to astrocytomas (ASTROCYTOMA) or glioblastoma multiforme (see GLIOBLASTOMA). Oligodendrocytes give rise to oligodendrogliomas (OLIGODENDROGLIOMA) and ependymocytes may undergo transformation to become EPENDYMOMA; CHOROID PLEXUS NEOPLASMS; or colloid cysts of the third ventricle. (From Escourolle et al., Manual of Basic Neuropathology, 2nd ed, p21)

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Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

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