NCT02355535

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

(STM-03) Phase I Study of Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Vanquish Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This Phase I dose escalation study will evaluate Procaspase Activating Compound-1 (PAC-1), a small molecule that activates procaspase -3 to caspase-3, resulting in apoptosis of cancer cells, in patients with advanced malignancies. As of March 1, 2019, only patients with neuroendocrine tumors will be enrolled in Component 1 of this study. PAC-1 is taken orally on days 1-21 of a 28-day cycle. The maximum tolerated dose (MTD) of PAC-1 (5 dose levels) will be determined using a modified-Fibonacci dose-escalation 3+3 design. Treatment continues until disease progression, unacceptable toxicity, physician discretion, or patient refusal.

Conditions

• Solid Tumor
• Pancreatic Neuroendocrine Tumor
• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	PAC-1	PAC-1 is taken orally on days 1-21 of a 28-day cycle.

Timeline

• Start date: 2015-02-01
• Primary completion: 2020-05-18
• Completion: 2020-05-18
• First posted: 2015-02-04
• Last updated: 2020-09-24

Locations

3 sites across 1 country: United States