Trial Outcomes & Findings for Glasdegib for Chronic Graft-Versus-Host Disease (NCT NCT04111497)
NCT ID: NCT04111497
Last Updated: 2024-10-29
Results Overview
Safety assessments will consist of monitoring and recording adverse events.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
From the start of treatment through 28 days after stopping study drug (Up to 25 months total)
Results posted on
2024-10-29
Participant Flow
Potentially eligible patients were approached at participating study centers during clinic visits.
After the participant signed and dated the Informed Consent Form (ICF), screening began. Once all screening procedures were completed and eligibility was confirmed, the participant was enrolled into the study. The screening period lasted from the date the participant signed consent until they completed the enrollment visit and started study drug.
Participant milestones
| Measure |
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.
Glasdegib: Given PO
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
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.
Glasdegib: Given PO
|
|---|---|
|
Overall Study
relapse of primary disease
|
1
|
|
Overall Study
toxicity and/or lack of efficacy
|
13
|
Baseline Characteristics
Glasdegib for Chronic Graft-Versus-Host Disease
Baseline characteristics by cohort
| Measure |
Treatment (Glasdegib)
n=15 Participants
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.
Glasdegib: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
64.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the start of treatment through 28 days after stopping study drug (Up to 25 months total)Safety assessments will consist of monitoring and recording adverse events.
Outcome measures
| Measure |
Treatment (Glasdegib)
n=15 Participants
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.
Glasdegib: Given PO
|
CR+PR
Responders (Complete and Partial Response)
|
MR+SD+PD
Non-responders (Mixed Response, Stable Disease, and Progressive Disease)
|
|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event
Participants with an SAE and a non-serious AE
|
3 Participants
|
—
|
—
|
|
Number of Participants Who Experienced an Adverse Event
Participants with a non-serious AE only
|
6 Participants
|
—
|
—
|
|
Number of Participants Who Experienced an Adverse Event
Participants without any adverse events
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 months after starting glasdegibORR will be calculated according to (1) the response definitions of the National Institute of Health (NIH) Consensus Conference for (a) skin or joint scores (0-3), where improvement by at least 1 point is a partial response (PR) and return to score 0 is a complete response (CR), or (b) the photographic range of motion scale (0-25) where improvement by at least 1 point is a PR and return to score 25 is a CR; and (2) change in the 0-10 sclerotic severity scale where at least a 2 point improvement is a PR or return to 0 (CR). Non-responders are those with mixed response (improvement in one regard and worsening in another), unchanged (stable), and progression.
Outcome measures
| Measure |
Treatment (Glasdegib)
n=15 Participants
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.
Glasdegib: Given PO
|
CR+PR
Responders (Complete and Partial Response)
|
MR+SD+PD
Non-responders (Mixed Response, Stable Disease, and Progressive Disease)
|
|---|---|---|---|
|
Overall Response Rate (ORR) in Sclerotic Manifestations
Partial response
|
7 Participants
|
—
|
—
|
|
Overall Response Rate (ORR) in Sclerotic Manifestations
Mixed response
|
1 Participants
|
—
|
—
|
|
Overall Response Rate (ORR) in Sclerotic Manifestations
Unchanged
|
6 Participants
|
—
|
—
|
|
Overall Response Rate (ORR) in Sclerotic Manifestations
Progressive
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 months after the starting glasdegibORR will be calculated according to the response definitions of the NIH Consensus Conference.
Outcome measures
| Measure |
Treatment (Glasdegib)
n=15 Participants
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.
Glasdegib: Given PO
|
CR+PR
Responders (Complete and Partial Response)
|
MR+SD+PD
Non-responders (Mixed Response, Stable Disease, and Progressive Disease)
|
|---|---|---|---|
|
ORR in All Chronic Graft Versus Host Disease (cGVHD) Manifestations
ORR for all manifestations of chronic GVHD · partial response
|
8 Participants
|
—
|
—
|
|
ORR in All Chronic Graft Versus Host Disease (cGVHD) Manifestations
ORR for all manifestations of chronic GVHD · mixed response
|
1 Participants
|
—
|
—
|
|
ORR in All Chronic Graft Versus Host Disease (cGVHD) Manifestations
ORR for all manifestations of chronic GVHD · unchanged
|
5 Participants
|
—
|
—
|
|
ORR in All Chronic Graft Versus Host Disease (cGVHD) Manifestations
ORR for all manifestations of chronic GVHD · progressive
|
1 Participants
|
—
|
—
|
|
ORR in All Chronic Graft Versus Host Disease (cGVHD) Manifestations
ORR for sclerotic manifestations · partial response
|
8 Participants
|
—
|
—
|
|
ORR in All Chronic Graft Versus Host Disease (cGVHD) Manifestations
ORR for sclerotic manifestations · mixed response
|
1 Participants
|
—
|
—
|
|
ORR in All Chronic Graft Versus Host Disease (cGVHD) Manifestations
ORR for sclerotic manifestations · unchanged
|
5 Participants
|
—
|
—
|
|
ORR in All Chronic Graft Versus Host Disease (cGVHD) Manifestations
ORR for sclerotic manifestations · progressive
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: Five patients censored because they left the study before month 12
Failure-free survival will be estimated using the Kaplan-Meier method (product limit estimator), with death, relapse, or start of another systemic immunosuppressive agent considered as events. Patients lost to follow-up or who withdraw consent will be censored.
Outcome measures
| Measure |
Treatment (Glasdegib)
n=15 Participants
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.
Glasdegib: Given PO
|
CR+PR
Responders (Complete and Partial Response)
|
MR+SD+PD
Non-responders (Mixed Response, Stable Disease, and Progressive Disease)
|
|---|---|---|---|
|
Failure-free Survival
|
37 percentage
Interval 10.0 to 64.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 4 (day 85) and End of Treatment (up through 24 months) [Due to lack of adequate data at cycles 7 (day 169) and 10 (day 253), they are not presented.]Population: Data not available for 5 and 4 participants for the Cycle 4 and End of Treatment visits, respectively.
Subjects will provide assessments of their symptom burden using a validated instrument recommended by the NIH Consensus on Chronic GVHD (Lee Chronic GVHD Symptom Scale). These will be collected before starting glasdegib on day 1 of cycle 1, and again on day (D)1, cycles 4, 7, 10 and end of treatment. Summary scores will be calculated based on published algorithms with absolute changes from baseline and clinically meaningful changes described for the population as a whole and based on CR+PR versus (vs.) stable disease (SD)+mixed response (MR)+progressive disease (PD), when adequate data are available for analysis. Lee Symptom Scale: minimum 0, maximum 100; higher score is worse outcome. Due to lack of adequate data at cycles 7 and 10, only Cycle 4 and End of Treatment are presented
Outcome measures
| Measure |
Treatment (Glasdegib)
n=11 Participants
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.
Glasdegib: Given PO
|
CR+PR
n=7 Participants
Responders (Complete and Partial Response)
|
MR+SD+PD
n=4 Participants
Non-responders (Mixed Response, Stable Disease, and Progressive Disease)
|
|---|---|---|---|
|
Symptom Burden Assessment - Absolute Change
End of Treatment
|
2.8 score on a scale
Standard Deviation 9.9
|
6.8 score on a scale
Standard Deviation 10.5
|
-4.1 score on a scale
Standard Deviation 1.8
|
|
Symptom Burden Assessment - Absolute Change
Cycle 4 (Day 85)
|
2.5 score on a scale
Standard Deviation 6.9
|
4.9 score on a scale
Standard Deviation 6.9
|
-3.0 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Cycle 4 (day 85) and End of Treatment (up through 24 months) [Due to lack of adequate data at cycles 7 (day 169) and 10 (day 253) they are not presented.]Population: Data not available for 5 participants at Cycle 4 and 4 participants for End of Treatment (EOT)
Subjects will provide assessments of their quality of life using the NIH-endorsed Patient Reported Outcomes Measurement Information System (PROMIS)-29. These will be collected before starting glasdegib on day 1 of cycle 1, and again on day (D)1, cycles 4, 7, 10 and end of treatment. Scores will be calculated based on published algorithms with absolute changes from baseline for the population as a whole and based on CR+PR versus stable disease (SD)+mixed response (MR)+progressive disease (PD), when adequate data are available for analysis. PROMIS-29 theoretical minimums and maximums are as follows: Physical Function: 22.5-57.0 Depression: 41.0-79.4 Anxiety: 40.3-81.6 Sleep Disturbance: 32.0-73.3 Fatigue: 33.7-75.8 Ability to Participate in Social Roles: 27.5-64.2 Pain Interference: 41.6-75.6 Higher score means a better outcome for Physical Function, Sleep Disturbance, and Social Roles. Higher score means a worse outcome for Anxiety, Depression, Fatigue, and Pain Interference.
Outcome measures
| Measure |
Treatment (Glasdegib)
n=11 Participants
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.
Glasdegib: Given PO
|
CR+PR
n=7 Participants
Responders (Complete and Partial Response)
|
MR+SD+PD
n=4 Participants
Non-responders (Mixed Response, Stable Disease, and Progressive Disease)
|
|---|---|---|---|
|
Quality of Life Assessment
Cycle 4 (day 85) - Physical Function absolute change
|
0.3 score on a scale
Standard Error 5.2
|
0.8 score on a scale
Standard Error 6.2
|
-0.9 score on a scale
Standard Error 2.2
|
|
Quality of Life Assessment
Cycle 4 (day 85) - Anxiety absolute change
|
2.1 score on a scale
Standard Error 5.9
|
1.6 score on a scale
Standard Error 6.8
|
3.4 score on a scale
Standard Error 3.9
|
|
Quality of Life Assessment
Cycle 4 (day 85) - Depression absolute change
|
0.3 score on a scale
Standard Error 8.2
|
-0.6 score on a scale
Standard Error 9.6
|
2.2 score on a scale
Standard Error 3.9
|
|
Quality of Life Assessment
Cycle 4 (day 85) - Fatigue absolute change
|
-0.4 score on a scale
Standard Error 6.8
|
-2.7 score on a scale
Standard Error 6.7
|
4.9 score on a scale
Standard Error 3.7
|
|
Quality of Life Assessment
Cycle 4 (day 85) - Sleep Disturbance absolute change
|
0.5 score on a scale
Standard Error 5.5
|
1.4 score on a scale
Standard Error 5.8
|
-1.6 score on a scale
Standard Error 5.0
|
|
Quality of Life Assessment
Cycle 4 (day 85) - Ability to Participate in Social Roles absolute change
|
2.1 score on a scale
Standard Error 7.4
|
2.7 score on a scale
Standard Error 8.9
|
0.6 score on a scale
Standard Error 2.8
|
|
Quality of Life Assessment
Cycle 4 (day 85) - Pain Interference absolute change
|
-1.8 score on a scale
Standard Error 9.9
|
-5.8 score on a scale
Standard Error 7.7
|
7.6 score on a scale
Standard Error 8.7
|
|
Quality of Life Assessment
End of Treatment - Physical Function absolute change
|
-0.1 score on a scale
Standard Error 4.9
|
-0.1 score on a scale
Standard Error 6.0
|
0.1 score on a scale
Standard Error 2.5
|
|
Quality of Life Assessment
End of Treatment - Anxiety absolute change
|
0.8 score on a scale
Standard Error 5.3
|
2.5 score on a scale
Standard Error 4.4
|
-2.1 score on a scale
Standard Error 6.0
|
|
Quality of Life Assessment
End of Treatment - Depression absolute change
|
0.2 score on a scale
Standard Error 5.0
|
-0.2 score on a scale
Standard Error 5.7
|
1.0 score on a scale
Standard Error 4.0
|
|
Quality of Life Assessment
End of Treatment - Fatigue absolute change
|
-1.7 score on a scale
Standard Error 5.1
|
-0.7 score on a scale
Standard Error 4.1
|
-3.5 score on a scale
Standard Error 6.8
|
|
Quality of Life Assessment
End of Treatment - Sleep Disturbance absolute change
|
1.3 score on a scale
Standard Error 5.0
|
0.3 score on a scale
Standard Error 4.1
|
2.9 score on a scale
Standard Error 6.7
|
|
Quality of Life Assessment
End of Treatment - Ability to Participate in Social Roles absolute change
|
-0.5 score on a scale
Standard Error 5.1
|
-2.3 score on a scale
Standard Error 5.5
|
2.7 score on a scale
Standard Error 2.0
|
|
Quality of Life Assessment
End of Treatment - Pain Interference absolute change
|
3.1 score on a scale
Standard Error 8.7
|
2.4 score on a scale
Standard Error 9.2
|
4.4 score on a scale
Standard Error 9.0
|
SECONDARY outcome
Timeframe: Up to 12 monthsBanking of blood and skin biopsy material for future biologic studies of hedgehog pathway inhibition.
Outcome measures
| Measure |
Treatment (Glasdegib)
n=15 Participants
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.
Glasdegib: Given PO
|
CR+PR
Responders (Complete and Partial Response)
|
MR+SD+PD
Non-responders (Mixed Response, Stable Disease, and Progressive Disease)
|
|---|---|---|---|
|
Biologic Impact of Hedgehog Pathway Inhibition
|
15 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 4 (day 85) and End of Treatment (up through 24 months) [Due to lack of adequate data at cycles 7 (day 169) and 10 (day 253), they are not presented.]Population: Data not available for 5 and 4 participants at the Cycle 4 and End of Treatment (EOT) visits, respectively.
Subjects will provide assessments of their symptom burden using a validated instrument recommended by the NIH Consensus on Chronic GVHD (Lee Chronic GVHD Symptom Scale). These will be collected before starting glasdegib on day 1 of cycle 1, and again on day (D)1, cycles 4, 7, 10 and end of treatment. Summary scores will be calculated based on published algorithms with absolute changes from baseline and clinically meaningful changes described for the population as a whole and based on CR+PR versus (vs.) stable disease (SD)+mixed response (MR)+progressive disease (PD), when adequate data are available for analysis. Lee Symptom Scale: minimum 0, maximum 100; higher score is worse outcome. Due to lack of adequate data at cycles 7 and 10, only Cycle 4 and End of Treatment are presented
Outcome measures
| Measure |
Treatment (Glasdegib)
n=11 Participants
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.
Glasdegib: Given PO
|
CR+PR
n=7 Participants
Responders (Complete and Partial Response)
|
MR+SD+PD
n=4 Participants
Non-responders (Mixed Response, Stable Disease, and Progressive Disease)
|
|---|---|---|---|
|
Symptom Burden Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) · Better
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Symptom Burden Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) · No change
|
6 Participants
|
3 Participants
|
0 Participants
|
|
Symptom Burden Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) · Worse
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Symptom Burden Assessment - Clinically Meaningful Change
End of Treatment · Better
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Symptom Burden Assessment - Clinically Meaningful Change
End of Treatment · No change
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Symptom Burden Assessment - Clinically Meaningful Change
End of Treatment · Worse
|
4 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 4 (Day 85) and End of Treatment (up through 24 months) [Due to lack of adequate data at cycles 7 (day 169) and 10 (day 253) they are not presented.]Population: Data not available for 5 and 4 participants at the Cycle 4 and End of Treatment (EOT) visits, respectively.
Subjects will provide assessments of their quality of life using the NIH-endorsed Patient Reported Outcomes Measurement Information System (PROMIS)-29. These will be collected before starting glasdegib on day 1 of cycle 1, and again on day (D)1, cycles 4, 7, 10 and end of treatment. Scores for physical functioning will be calculated based on published algorithms with clinically meaningful changes described for the population as a whole and based on CR+PR versus (vs.) stable disease (SD)+mixed response (MR)+progressive disease (PD), when adequate data are available for analysis. PROMIS-29 minimums and maximums as follows: Physical Function: 22.5-57.0 Depression: 41.0-79.4 Anxiety: 40.3-81.6 Sleep Disturbance: 32.0-73.3 Fatigue: 33.7-75.8 Ability to Participate in Social Roles: 27.5-64.2 Pain Interference: 41.6-75.6 Higher score means a better outcome for Physical Function, Sleep, and Social Roles. Higher score means a worse outcome for Anxiety, Depression, Fatigue, and Pain.
Outcome measures
| Measure |
Treatment (Glasdegib)
n=11 Participants
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.
Glasdegib: Given PO
|
CR+PR
n=7 Participants
Responders (Complete and Partial Response)
|
MR+SD+PD
n=4 Participants
Non-responders (Mixed Response, Stable Disease, and Progressive Disease)
|
|---|---|---|---|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) - Physical Function clinically meaningful change · Better
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) - Physical Function clinically meaningful change · No change
|
8 Participants
|
5 Participants
|
3 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) - Physical Function clinically meaningful change · Worse
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) - Anxiety clinically meaningful change · Better
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) - Anxiety clinically meaningful change · No change
|
6 Participants
|
4 Participants
|
2 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) - Anxiety clinically meaningful change · Worse
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85)- Depression clinically meaningful change · Better
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85)- Depression clinically meaningful change · No change
|
6 Participants
|
4 Participants
|
2 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85)- Depression clinically meaningful change · Worse
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85)- Fatigue clinically meaningful change · Better
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85)- Fatigue clinically meaningful change · No change
|
7 Participants
|
5 Participants
|
2 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85)- Fatigue clinically meaningful change · Worse
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) - Sleep Disturbance clinically meaningful change · Better
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) - Sleep Disturbance clinically meaningful change · No change
|
6 Participants
|
4 Participants
|
2 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) - Sleep Disturbance clinically meaningful change · Worse
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) - Ability to Participate in Social Roles clinically meaningful change · Better
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) - Ability to Participate in Social Roles clinically meaningful change · No change
|
6 Participants
|
3 Participants
|
3 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) - Ability to Participate in Social Roles clinically meaningful change · Worse
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) - Pain Interference clinically meaningful change · Better
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) - Pain Interference clinically meaningful change · No change
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
Cycle 4 (Day 85) - Pain Interference clinically meaningful change · Worse
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Physical Function clinically meaningful change · Better
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Physical Function clinically meaningful change · No change
|
9 Participants
|
5 Participants
|
4 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Physical Function clinically meaningful change · Worse
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Anxiety clinically meaningful change · Better
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Anxiety clinically meaningful change · No change
|
8 Participants
|
5 Participants
|
3 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Anxiety clinically meaningful change · Worse
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Depression clinically meaningful change · Better
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Depression clinically meaningful change · No change
|
8 Participants
|
5 Participants
|
3 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Depression clinically meaningful change · Worse
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Fatigue clinically meaningful change · Better
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Fatigue clinically meaningful change · No change
|
8 Participants
|
6 Participants
|
2 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Fatigue clinically meaningful change · Worse
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Sleep Disturbance clinically meaningful change · Better
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Sleep Disturbance clinically meaningful change · No change
|
8 Participants
|
6 Participants
|
2 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Sleep Disturbance clinically meaningful change · Worse
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Ability to Participate in Social Roles clinically meaningful change · Better
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Ability to Participate in Social Roles clinically meaningful change · No change
|
10 Participants
|
6 Participants
|
4 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Ability to Participate in Social Roles clinically meaningful change · Worse
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Pain Interference clinically meaningful change · Better
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Pain Interference clinically meaningful change · No change
|
7 Participants
|
4 Participants
|
3 Participants
|
|
Quality of Life Assessment - Clinically Meaningful Change
End of Treatment - Pain Interference clinically meaningful change · Worse
|
3 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
Treatment (Glasdegib)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment (Glasdegib)
n=15 participants at risk
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.
Glasdegib: Given PO
|
|---|---|
|
Musculoskeletal and connective tissue disorders
acute myopathy
|
6.7%
1/15 • Number of events 1 • The AE reporting period for this study began when the participant received their first dose of study drug and ended with the EOT visit, or 28 days after the last dose of study drug, whichever was later. Exceptions to this reporting period were (a) any AE occurring due to a protocol-specific screening procedure; and (b) any SAE occuring beyond 28 days after the last dose of glasdegib AND assessed by the investigator as possibly related to glasdegib.
The study collected Grade 3 and above adverse events, with these exceptions: An abnormal lab value; unless it led to discontinuation, delay, or modification in treatment, therapeutic intervention, the investigator considered it to be clinically significant, or it met seriousness criteria. Chronic GVHD manifestations were not collected as AE's unless they meet seriousness criteria. Hospitalization for elective treatment of a stable pre-existing condition was not considered an adverse event.
|
|
Infections and infestations
upper respiratory infection
|
6.7%
1/15 • Number of events 1 • The AE reporting period for this study began when the participant received their first dose of study drug and ended with the EOT visit, or 28 days after the last dose of study drug, whichever was later. Exceptions to this reporting period were (a) any AE occurring due to a protocol-specific screening procedure; and (b) any SAE occuring beyond 28 days after the last dose of glasdegib AND assessed by the investigator as possibly related to glasdegib.
The study collected Grade 3 and above adverse events, with these exceptions: An abnormal lab value; unless it led to discontinuation, delay, or modification in treatment, therapeutic intervention, the investigator considered it to be clinically significant, or it met seriousness criteria. Chronic GVHD manifestations were not collected as AE's unless they meet seriousness criteria. Hospitalization for elective treatment of a stable pre-existing condition was not considered an adverse event.
|
|
Infections and infestations
mastitis
|
6.7%
1/15 • Number of events 1 • The AE reporting period for this study began when the participant received their first dose of study drug and ended with the EOT visit, or 28 days after the last dose of study drug, whichever was later. Exceptions to this reporting period were (a) any AE occurring due to a protocol-specific screening procedure; and (b) any SAE occuring beyond 28 days after the last dose of glasdegib AND assessed by the investigator as possibly related to glasdegib.
The study collected Grade 3 and above adverse events, with these exceptions: An abnormal lab value; unless it led to discontinuation, delay, or modification in treatment, therapeutic intervention, the investigator considered it to be clinically significant, or it met seriousness criteria. Chronic GVHD manifestations were not collected as AE's unless they meet seriousness criteria. Hospitalization for elective treatment of a stable pre-existing condition was not considered an adverse event.
|
Other adverse events
| Measure |
Treatment (Glasdegib)
n=15 participants at risk
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.
Glasdegib: Given PO
|
|---|---|
|
Musculoskeletal and connective tissue disorders
muscle cramping
|
33.3%
5/15 • Number of events 5 • The AE reporting period for this study began when the participant received their first dose of study drug and ended with the EOT visit, or 28 days after the last dose of study drug, whichever was later. Exceptions to this reporting period were (a) any AE occurring due to a protocol-specific screening procedure; and (b) any SAE occuring beyond 28 days after the last dose of glasdegib AND assessed by the investigator as possibly related to glasdegib.
The study collected Grade 3 and above adverse events, with these exceptions: An abnormal lab value; unless it led to discontinuation, delay, or modification in treatment, therapeutic intervention, the investigator considered it to be clinically significant, or it met seriousness criteria. Chronic GVHD manifestations were not collected as AE's unless they meet seriousness criteria. Hospitalization for elective treatment of a stable pre-existing condition was not considered an adverse event.
|
|
Metabolism and nutrition disorders
hyponatremia
|
13.3%
2/15 • Number of events 2 • The AE reporting period for this study began when the participant received their first dose of study drug and ended with the EOT visit, or 28 days after the last dose of study drug, whichever was later. Exceptions to this reporting period were (a) any AE occurring due to a protocol-specific screening procedure; and (b) any SAE occuring beyond 28 days after the last dose of glasdegib AND assessed by the investigator as possibly related to glasdegib.
The study collected Grade 3 and above adverse events, with these exceptions: An abnormal lab value; unless it led to discontinuation, delay, or modification in treatment, therapeutic intervention, the investigator considered it to be clinically significant, or it met seriousness criteria. Chronic GVHD manifestations were not collected as AE's unless they meet seriousness criteria. Hospitalization for elective treatment of a stable pre-existing condition was not considered an adverse event.
|
|
Metabolism and nutrition disorders
hypokalemia
|
13.3%
2/15 • Number of events 2 • The AE reporting period for this study began when the participant received their first dose of study drug and ended with the EOT visit, or 28 days after the last dose of study drug, whichever was later. Exceptions to this reporting period were (a) any AE occurring due to a protocol-specific screening procedure; and (b) any SAE occuring beyond 28 days after the last dose of glasdegib AND assessed by the investigator as possibly related to glasdegib.
The study collected Grade 3 and above adverse events, with these exceptions: An abnormal lab value; unless it led to discontinuation, delay, or modification in treatment, therapeutic intervention, the investigator considered it to be clinically significant, or it met seriousness criteria. Chronic GVHD manifestations were not collected as AE's unless they meet seriousness criteria. Hospitalization for elective treatment of a stable pre-existing condition was not considered an adverse event.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
6.7%
1/15 • Number of events 1 • The AE reporting period for this study began when the participant received their first dose of study drug and ended with the EOT visit, or 28 days after the last dose of study drug, whichever was later. Exceptions to this reporting period were (a) any AE occurring due to a protocol-specific screening procedure; and (b) any SAE occuring beyond 28 days after the last dose of glasdegib AND assessed by the investigator as possibly related to glasdegib.
The study collected Grade 3 and above adverse events, with these exceptions: An abnormal lab value; unless it led to discontinuation, delay, or modification in treatment, therapeutic intervention, the investigator considered it to be clinically significant, or it met seriousness criteria. Chronic GVHD manifestations were not collected as AE's unless they meet seriousness criteria. Hospitalization for elective treatment of a stable pre-existing condition was not considered an adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place