ABOUT THIS STUDY
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- Diagnosed with moderate or severe cGVHD according to the 2014 National Institute of Health (NIH) Consensus Criteria
- Diagnosed with cGVHD-related sclerosis or fasciitis
- Skin feature score of at least 2 OR
- Joints and fascia score of at least 1
- Stable or progressive sclerosis/fasciitis despite treatment with at least one prior line of systemic therapy for cGVHD
- Female patients who:
- Are documented to be postmenopausal or are surgically sterile, OR
- If of childbearing potential, agree to use at least 1 highly effective method of contraception from the time of signing the informed consent form through 30 days after the last dose of study drug, OR agree to practice true abstinence or exclusively non-heterosexual activity when this is in line with the preferred and usual lifestyle of the subject
- Male patients who:
- Are surgically sterile (vasectomized) OR
- Agree to use at least 1 highly effective method of contraception during the entire study treatment period and through 30 days after the last dose of study drug, OR agree to practice true abstinence or exclusively non-heterosexual activity when this is in line with the preferred and usual lifestyle of the subject, AND
- Agree to use a condom to prevent potential transmission of investigational drug in seminal fluid
- Absolute neutrophil count (ANC) > 1000/uL
- Platelet count > 50 x 10^9/mL
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2 x upper limit of normal (ULN) unless attributed to cGVHD
- Normal total bilirubin unless attributed to cGVHD
- Creatinine < 2.0 mg/dl
- Hospitalization for evaluation or management of an infection within the last 8 weeks
- Known organ dysfunction
- Uncontrolled cardiovascular disease, including arrhythmias, congestive heart
failure
- Oxygen requirement
- Addition of any new systemic immunosuppressive treatment within the last 2 weeks
* Addition of new systemic immunosuppressive treatment along with glasdegib is also
prohibited
- Corrected QT (QTc) interval > 480 ms
- Female patients who are lactating or have a positive serum pregnancy test
- Major surgery within 14 days before enrollment
* Does not include placement of venous access device, bone marrow biopsy, GVHD
diagnostic biopsy, or other routine procedures in chronic GVHD or post-transplantation
care
- Use of any concomitant medications meds that are prohibited within the past 7 days
- Any serious medical or psychiatric illness that could, in the investigator's opinion,
potentially interfere with the completion of treatment according to this protocol
- Known intolerance to glasdegib, sonidegib, or vismodegib
- Non-hematologic malignancy within the past 2 years with the exception of:
- Adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid
cancer
- Carcinoma in situ of the cervix or breast
- Prostate cancer of Gleason grade 6 or less with stable prostate-specific antigen
levels
- Cancer considered cured by surgical resection or unlikely to impact survival
during the duration of the study
- Treatment with non-Food and Drug Administration (FDA) approved drug within 21 days of
start of this trial
- Evidence of recurrent or progressive underlying malignant disease
- Karnofsky performance status < 70%
- History of non-compliance
- Life expectancy < 6 months
- Grade 2 or 3 muscle cramping, or grade 1 muscle cramping that occurs at least weekly
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Descriptive Information | |||||
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Brief Title ICMJE | Glasdegib for Chronic Graft-Versus-Host Disease | ||||
Official Title ICMJE | A Single-Arm, Open-Label, Phase I/II Study of Glasdegib for Sclerotic Chronic Graft-Vs-Host Disease | ||||
Brief Summary | This phase I/II trial studies whether glasdegib is helpful in treating sclerosis associated with chronic graft-versus-host disease. It will also investigate the safety of glasdegib in treating patients with chronic graft-versus-host disease. | ||||
Detailed Description | OUTLINE: This is a phase I/II study. Patients receive glasdegib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE |
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Intervention ICMJE | Drug: Glasdegib
Given PO Other Names:
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Study Arms ICMJE | Experimental: Treatment (glasdegib)
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. Intervention: Drug: Glasdegib | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 20 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2022 | ||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04111497 | ||||
Other Study ID Numbers ICMJE | RG1005365 NCI-2019-03244 ( Registry Identifier: NCI / CTRP ) 8771 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) P30CA015704 ( U.S. NIH Grant/Contract ) | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Fred Hutchinson Cancer Research Center | ||||
Study Sponsor ICMJE | Fred Hutchinson Cancer Research Center | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Fred Hutchinson Cancer Research Center | ||||
Verification Date | August 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |