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

NCT03332355 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-05-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

PAC-1 Compound

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). PAC-1 will be taken in the morning on days 1-21 in each 28 day cycle. Temozolomide 150 mg/m2 dose is 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.

Sponsors & Collaborators

  • University of Illinois at Chicago

    collaborator OTHER

  • Vanquish Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Oana C Danciu, M.D. · Unversity of Illinois at Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03332355 on ClinicalTrials.gov