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

Contact Investigators or Research Sites near you

Start Over

Johns Hopkins Cancer Center

Baltimore, MD United States
  Connect »

Regions Hospital

Saint Paul, MN United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.