Last updated on March 2019

Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 2

Brief description of study

The primary objectives of this study are to determine the maximal tolerated dose (MTD) of PAC-1 in combination with temozolomide in patients with high grade glioma: glioblastoma multiforme (GBM) or anaplastic astrocytoma after progression following standard first line therapy (Component 2), by evaluation of toxicity and tolerability.

Detailed Study Description

PAC-1 in combination with temozolomide (Component 2): after the MTD is established for single agent PAC-1 in Component 1, a modified-Fibonacci dose-escalation 3+3 design starts in Component 2, at a PAC-1 dose one level lower than the MTD of PAC-1 established in the single agent PAC-1 component (i.e., Component 1) and 150 mg/m2 dose of temozolomide given for the 5 days starting at day 8 of cycle 1 in cohorts of 3-6 patients. The combination cohort that reaches MTD will expanded to at least 9 patients, similar to the PAC-1 alone cohort at MTD. For all dose cohorts, pharmacokinetics of PAC-1 will be assessed following doses administered on days 1 and 11 of the first cycle. Temozolomide pharmacokinetics will be performed on Day 11 of the first cycle.

Clinical Study Identifier: NCT03332355

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