NCT02232243

HCQ on PAR-4 Levels in Patients With Resectable Solid Tumors

A Pilot Study to Determine the Biological Effects of Hydroxychloroquine on PAR-4 Levels in Patients With Resectable Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Peng Wang, MD PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Baseline levels of PAR-4 secreted by normal cells are generally inadequate to cause massive apoptosis in cancer cells and drugs that bolster the secretion of PAR-4 would constitute an important therapeutic advance.The apoptosis sensitizing features of hydroxychloroquine enhance the anti-tumor effects of a broad range of cancer therapeutics. The investigators hypothesize that hydroxychloroquine will induce at least 2-fold increase in systemic (plasma) PAR-4 levels compared to pre-treatment plasma levels in patients with resectable solid tumors.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine, 200mg twice dailiy	Hydroxychloroquine, 200mg twice daily (400mg/day total) was given to subjects for up to 14 days prior to surgery.
DRUG	Hydroxychloroquine, 400mg twice daily	Hydroxychloroquine, 400mg twice daily (800mg/day total) was given to subjects for up to 14 days prior to surgery.

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-01-01
• Completion: 2018-12-01
• First posted: 2014-09-05
• Last updated: 2021-06-28
• Results posted: 2019-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study