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Hedgehog Pathway Inhibitor

Glasdegib for Graft-versus-Host Disease

Phase 1 & 2
Waitlist Available
Led By Stephanie Lee
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months
Awards & highlights

Study Summary

This trial will study whether glasdegib is helpful in treating sclerosis associated with chronic graft-versus-host disease, as well as the safety of glasdegib in treating patients with chronic graft-versus-host disease.

Eligible Conditions
  • Chronic Graft-versus-Host Disease
  • Plantar Fasciitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Biologic impact of hedgehog pathway inhibition
Failure-free survival
ORR in all chronic graft versus host disease (cGVHD) manifestations
+3 more

Side effects data

From 2022 Phase 3 trial • 14 Patients • NCT04842604
44%
Neutropenia
11%
Fall
11%
Diarrhoea
11%
Febrile neutropenia
11%
Thrombocytopenia
11%
Colitis ulcerative
11%
Anaemia
11%
COVID-19 pneumonia
11%
Corynebacterium bacteraemia
11%
Inguinal hernia
11%
Retinal detachment
11%
C-reactive protein increased
11%
Vomiting
11%
Cardiopulmonary failure
11%
Colitis
11%
Epstein-Barr virus infection reactivation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Azacitidine
Glasdegib + Azacitidine

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (glasdegib)Experimental Treatment1 Intervention
Patients receive glasdegib PO QD on days 1-28. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glasdegib
2015
Completed Phase 3
~100

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,230 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,253 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
10 Patients Enrolled for Graft-versus-Host Disease
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,859 Total Patients Enrolled

Media Library

Glasdegib (Hedgehog Pathway Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04111497 — Phase 1 & 2
Graft-versus-Host Disease Research Study Groups: Treatment (glasdegib)
Graft-versus-Host Disease Clinical Trial 2023: Glasdegib Highlights & Side Effects. Trial Name: NCT04111497 — Phase 1 & 2
Glasdegib (Hedgehog Pathway Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04111497 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being researched in this trial?

"The recruitment window for this trial has been closed. The research was first advertised on December 3rd, 2019 and the last update happened June 13th 2022. If you are looking to participate in other studies, there are 200 trials involving plantar fasciitis patients and 8 clinical studies with Glasdegib currently accepting participants."

Answered by AI

Is this investigation unprecedented in its trial format?

"Currently, Glasdegib has 8 ongoing clinical trials across 19 cities and 12 countries. In 2014, Pfizer initiated the first trial of its kind with 48 participants who completed Phase 1 drug approval. Since then, 15 studies have concluded successfully."

Answered by AI

Are there any auxiliary research studies that have utilized Glasdegib?

"Presently, 8 clinical trials for Glasdegib are underway with 3 in Phase 3. While Houston is a hub of activity, there are 106 facilities across the US utilizing this drug to study patient outcomes."

Answered by AI

Is the enrollment process for this trial still open?

"At this juncture, this experiment is not enrolling candidates. It was initially posted on December 3rd 2019 and the last changes were made to it on June 13th 2022. For those who are interested in other available clinical trials, there are 200 for plantar fasciitis and 8 related to Glasdegib that require participants."

Answered by AI
~3 spots leftby Apr 2025