NCT03051477

Trial of Mistletoe Extract in Patients With Advanced Solid Tumors

A Phase I Dose Escalating Trial of Mistletoe Extract in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study will seek to determine the safety and toxicity profile as well as the maximum tolerated dose of Helixor® M in patients with advanced solid tumors.

Detailed description

This study is a Phase I study that consists of two phases: a dose escalation phase and an expansion phase. The dose escalation phase will be used to evaluate the safety and toxicity of Helixor® M (mistletoe extract). An accelerated titration design (ATD) will be utilized to determine the MTD. The expansion phase will be used to obtain preliminary efficacy data about Helixor® M.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Helixor® M	3-hour IV infusion on Monday, Wednesday, and Friday of each week.

Timeline

• Start date: 2017-03-01
• Primary completion: 2021-01-29
• Completion: 2022-08-05
• First posted: 2017-02-13
• Last updated: 2022-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study