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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
No Placebo-Only Group
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
- Hernia
- Plantar Fasciitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Who Experienced an Adverse Event
Secondary study objectives
Biologic Impact of Hedgehog Pathway Inhibition
Failure-free Survival
ORR in All Chronic Graft Versus Host Disease (cGVHD) Manifestations
+5 moreSide effects data
From 2022 Phase 3 trial • 14 Patients • NCT0484260444%
Neutropenia
11%
Febrile neutropenia
11%
Anaemia
11%
Thrombocytopenia
11%
Retinal detachment
11%
Inguinal hernia
11%
Cardiopulmonary failure
11%
Vomiting
11%
Fall
11%
COVID-19 pneumonia
11%
Corynebacterium bacteraemia
11%
Diarrhoea
11%
Epstein-Barr virus infection reactivation
11%
C-reactive protein increased
11%
Colitis
11%
Colitis ulcerative
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Azacitidine
Glasdegib + Azacitidine
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
147,979 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
569 Previous Clinical Trials
1,342,114 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
10 Patients Enrolled for Graft-versus-Host Disease
PfizerIndustry Sponsor
4,650 Previous Clinical Trials
17,743,648 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You experience moderate to severe muscle cramps, or mild muscle cramps that happen at least once a week.You have a known problem with one or more of your organs.You need to use oxygen to help you breathe.Your overall physical ability and health is below 70%.You have experienced bad reactions to glasdegib, sonidegib, or vismodegib in the past.You have visible signs of skin involvement (score of 2 or higher) or joint and fascia involvement (score of 1 or higher).You have less than 6 months to live.You had surgery to remove all of your cancer, or your cancer is not expected to affect your survival during the study.You have been diagnosed with a condition called chronic graft-versus-host disease (cGVHD) that causes sclerosis or fasciitis.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (glasdegib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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