Group 1 in Part 1/Part 2: Emactuzumab for TGCT

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Medstart Heart and Vascular Institute, Baltimore, MD
TGCT+2 More
Emactuzumab - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This is a multicenter, Phase 3, randomised, double-blind, placebo-controlled study, which aims to evaluate the efficacy and safety of the investigational drug emactuzumab for the treatment of patients with localized or diffuse TGCT where surgical removal of the tumor is not viewed as an option. The study consists of two parts. In Part 1, eligible subjects will be assigned in a 2:1 ratio to receive either emactuzumab or matching placebo in a double-blind fashion, that will be administered in total 5 times as an intravenous (i.v.) infusion once every 2 weeks. This will be followed by an observation period of 3 months leading to a total duration of 24 weeks in Part 1. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. Part 2 is a long-term double-blind follow-up phase of the subjects on emactuzumab or placebo. Subjects assigned to placebo in Part 1 have the option to crossover under certain circumstances to receive open-label emactuzumab in Part 2.

Eligible Conditions

  • TGCT

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for TGCT

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: up to 24 months

Month 6
Overall Response Rate (ORR)
up to 24 months
Duration of response (DoR)
Physical Function
Quality of Life (QoL)
Range of Motion (ROM)
Tumour volume score (TVS)
Worst Pain
Worst Stiffness

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for TGCT

Trial Design

2 Treatment Groups

Group 1 in Part 1/Part 2: Emactuzumab
1 of 2
Group 2 in Part 1 and Part 2: Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

128 Total Participants · 2 Treatment Groups

Primary Treatment: Group 1 in Part 1/Part 2: Emactuzumab · Has Placebo Group · Phase 3

Group 1 in Part 1/Part 2: Emactuzumab
Drug
Experimental Group · 1 Intervention: Emactuzumab · Intervention Types: Drug
Group 2 in Part 1 and Part 2: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emactuzumab
2015
Completed Phase 1
~260

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
Closest Location: Medstart Heart and Vascular Institute · Baltimore, MD
Photo of Baltimore  1Photo of Baltimore  2Photo of Baltimore  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching TGCT
0 CompletedClinical Trials

Eligibility Criteria

Age Any Age · All Participants · 5 Total Inclusion Criteria

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You are a woman of childbearing potential (WOCBP)

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.