Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002822-19 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An open-label study available to all eligible participants from Study B1371019 and participants originating from Study B1371012 continuing on study intervention with azacitidine with or without glasdegib.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants from B1371019 and B1371012 | Experimental | Azacitidine will be administered 75 mg/m2/day for 7 days every 28 days on Days 1-7 (±3 days) per local label or per the IP Manual (or SPC). Azacitidine may be administered by SC injection or IV infusion. Alternate dosing schedules to administer the 7 doses to accommodate participant and treatment center availability are allowed. The starting dose regimen will be the same as the most recent regimen received on the B1371019 or B1371012 study. Glasdegib 50, 75 or 100 mg will be orally administered daily and continuously. The starting dose regimen will be the same as the most recent regimen received on the B1371012 or B1371019 study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glasdegib | Drug | 25 mg or 100 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Event (AE) and Treatment Related AE | AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An AE was considered treatment emergent if the event occurred during the on-treatment period (regardless of if it was seen prior to the start of treatment). An AE was considered treatment related as assigned by the investigator. | From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days) |
| Number of Participants With Treatment Emergent Serious Adverse Events (SAE) and Treatment Related SAEs | A SAE was defined as any untoward medical occurrence that, at any dose that resulted in death; was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or other medical events as per investigator's judgement. A SAE was considered treatment emergent if the event occurred during the on-treatment period (regardless of if it was seen prior to the start of treatment). A SAE was considered treatment related as assigned by the investigator. | From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU | Salzburg | 5020 | Austria | |||
Not provided
| Label | URL |
|---|---|
| B1371019 (NCT03416179) | View source |
Not provided
Not provided
Participants from non-intensive (NINT) cohort of study B1371019 (NCT03416179) or study B1371012 (NCT02367456) were enrolled in this open label, continuation study. A total of 14 participants were enrolled in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Glasdegib + Azacitidine | Participants received glasdegib 100 milligrams (mg) tablet per oral (PO) once a day (QD) in combination with azacitidine 75 mg per meter squared (m^2)/day as subcutaneous (SC) injection or intravenous (IV) infusion for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2021 | Nov 27, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Azacitidine | Drug | 100 mg/vial powder for 25 mg/mL suspension for injection |
|
| Uniklinikum Salzburg, Landeskrankenhaus Salzburg |
| Salzburg |
| 5020 |
| Austria |
| Health Sciences Centre | Winnipeg | Manitoba | R3A 1R9 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Ustavni lekarna | Ostrava - Poruba | 708 52 | Czechia |
| Klinika hematoonkologie | Ostrava-Poruba | 708 52 | Czechia |
| CHU de Nantes Hotel Dieu | Nantes | 44093 | France |
| CHU de Nantes | Nantes | 44093 | France |
| Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek | Debrecen | 4032 | Hungary |
| Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika | Debrecen | 4032 | Hungary |
| AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia | Torrette Di Ancona | Ancona | 60126 | Italy |
| SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi | Torette Di Ancona | AN | 60126 | Italy |
| University of Fukui Hospital | Yoshida-gun | Fukui | 910-1193 | Japan |
| Osaka City University Hospital | Osaka | Osaka | 545-8586 | Japan |
| Instituto Nacional de CancerologÃa | México | MÉX | 14080 | Mexico |
| WWCOiT im. M. Kopemlka w Lodzl | Lodz | 93-513 | Poland |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| The Royal Marsden NHS Foundation Trust | Sutton | Surry | SM2 5PT | United Kingdom |
| FG001 | Placebo + Azacitidine | Participants received placebo matched to Glasdegib in combination with azacitidine 75mg/m^2/day SC or IV for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included all participants who receive at least one dose of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Glasdegib + Azacitidine | Participants received glasdegib 100 milligrams (mg) tablet per oral (PO) once a day (QD) in combination with azacitidine 75 mg per meter squared (m^2)/day as subcutaneous (SC) injection or intravenous (IV) infusion for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment. |
| BG001 | Placebo + Azacitidine | Participants received placebo matched to Glasdegib in combination with azacitidine 75mg/m^2/day SC or IV for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Event (AE) and Treatment Related AE | AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An AE was considered treatment emergent if the event occurred during the on-treatment period (regardless of if it was seen prior to the start of treatment). An AE was considered treatment related as assigned by the investigator. | Safety analysis set included all participants who receive at least one dose of study treatment. | Posted | Count of Participants | Participants | From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment Emergent Serious Adverse Events (SAE) and Treatment Related SAEs | A SAE was defined as any untoward medical occurrence that, at any dose that resulted in death; was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or other medical events as per investigator's judgement. A SAE was considered treatment emergent if the event occurred during the on-treatment period (regardless of if it was seen prior to the start of treatment). A SAE was considered treatment related as assigned by the investigator. | Safety analysis set included all participants who receive at least one dose of study treatment. | Posted | Count of Participants | Participants | From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days) |
|
From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glasdegib + Azacitidine | Participants received glasdegib 100 milligrams (mg) tablet per oral (PO) once a day (QD) in combination with azacitidine 75 mg per meter squared (m^2)/day as subcutaneous (SC) injection or intravenous (IV) infusion for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment. | 1 | 9 | 2 | 9 | 6 | 9 |
| EG001 | Placebo + Azacitidine | Participants received placebo matched to Glasdegib in combination with azacitidine 75mg/m^2/day SC or IV for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment. | 0 | 5 | 1 | 5 | 3 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Corynebacterium bacteraemia | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Epstein-Barr virus infection reactivation | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquires@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2021 | Nov 27, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000592580 | glasdegib |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants received placebo matched to Glasdegib in combination with azacitidine 75mg/m^2/day SC or IV for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment.
|
|