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Study to Evaluate Safety and MTD of Epidural Resiniferatoxin Injection for Treatment of Intractable Cancer Pain

NCT03226574 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-10-20

No results posted yet for this study

Summary

The study is a multicenter, open-label Phase 1b single dose escalation safety study for adult subjects with intractable pain associated with cancer in any area below the mid-thoracic level who meet all other eligibility criteria.

Conditions

  • Intractable Cancer Pain

Interventions

DRUG

Resiniferatoxin

single dose (0.4, 1, 2, 4, 8,15, 25 or 35 mcg), epidural injection

Sponsors & Collaborators

  • Sorrento Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Monica Luchi, MD · Sorrento Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2020-03-18
Completion
2020-06-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03226574 on ClinicalTrials.gov