Glasdegib for Chronic Graft-Versus-Host Disease

NCT04111497

Last updated date
Study Location
Duke University Medical Center
Durham, North Carolina, 27710, United States
Contact
206-667-7010

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Graft Versus Host Disease, Fasciitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Chronic Graft Versus Host Disease, FasciitisGlasdegib for Chronic Graft-Versus-Host Disease
NCT04111497
  1. Durham, North Carolina
  2. Salt Lake City, Utah
  3. Seattle, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Chronic Graft Versus Host Disease
  • Fasciitis
Intervention  ICMJE Drug: Glasdegib
Given PO
Other Names:
  • 1095173-27-5
  • PF 04449913
  • PF-04449913
  • PF04449913
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
 (submitted: September 30, 2019)
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:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marcie Hall206-667-7010[email protected]
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Fred Hutchinson Cancer Research Center
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Pfizer
Investigators  ICMJE
Principal Investigator:Stephanie LeeFred Hutch/University of Washington Cancer Consortium
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