APN401 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer, Colorectal Cancer, or Other Solid Tumors That Cannot Be Removed by Surgery

Stage IV Pancreatic Cancer Clinical Trial

Official title: Safety and Immunologic Activity of Multiple Infusions of APN401

Status Completed

Clinical Trial Summary

This phase I trial studies the side effects and best dose of APN401 in treating patients with pancreatic cancer, colorectal cancer, or other solid tumors that have spread to other places in the body or have come back. APN401 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the toxicities and establish the safety of multiple infusions of small interfering ribonucleic acid (siRNA)-transfected peripheral blood mononuclear cells APN401 (APN401).

SECONDARY OBJECTIVES:

I. To determine the immunologic effects of multiple infusions of APN401. II. To document clinical response and survival.

OUTLINE:

Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 intravenously (IV) over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 5 years. ;

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Neoplasms
• Metastatic Malignant Neoplasm in the Brain
• Metastatic Solid Neoplasm
• Neoplasms
• Pancreatic Neoplasms
• Recurrence
• Recurrent Colorectal Carcinoma
• Recurrent Pancreatic Carcinoma
• Recurrent Solid Neoplasm
• Stage IV Colorectal Cancer
• Stage IV Pancreatic Cancer
• Stage IVA Colorectal Cancer
• Stage IVA Pancreatic Cancer
• Stage IVB Colorectal Cancer
• Stage IVB Pancreatic Cancer
• Unresectable Solid Neoplasm

• NCT number: NCT03087591
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Status: Completed
• Phase: Phase 1
• Start date: April 28, 2017
• Completion date: December 8, 2020