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A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients (BRIGHT 1012)

Primary Purpose

Myelodysplastic Syndrome, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

PF-04449913 (Glasdegib)

Azacitidine

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring MDS, AML, CMML

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Patients must have previously untreated MDS, AML, or CMML according to the WHO 2016 classification.
MDS patients must have Intermediate (>3 to 4.5 points), High Risk (>4.5 - 6) or Very High Risk (>6 points) disease according to the Revised International Prognostic Scoring System 2012 (IPSS-R).
Clinical indication for treatment with azacitidine for MDS or AML.

Exclusion criteria:

Patients with AML who are candidates for standard induction chemotherapy as first line treatment.
Patients with known active CNS leukemia.
Prior treatment with a smoothened inhibitor (SMOi) and/or hypomethylating agent.

Sites / Locations

University of Alabama at Birmingham the Kirklin Clinic
University of Alabama at Birmingham
UC San Diego Moores Cancer Center
Smilow Cancer Center at Yale New Haven Hospital
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Montefiore Einstein Center for Cancer
Montefiore Medical Center
Roswell Park Cancer Institute
Stony Brook University Hospital Cancer Center
Stony Brook University
Duke University Health System: Adult Bone Marrow Transplant Clinic
Duke University Health System, Duke University Hospital
Duke University Health System
Investigational Chemotherapy Service
Cleveland Clinic Taussig Cancer Center
Henry-Joyce Cancer Center
Vanderbilt - Ingram Cancer Center
Huntsman Cancer Hospital
Huntsman Cancer Institute
Seattle Cancer Care Alliance (SCCA)
University of Washington Medical Center (UWMC)
Ziekenhuis Netwerk Antwerpen - Campus Stuivenberg
UZ Leuven
Tom Baker Cancer Center
University Of Alberta Hospital
CHU d'Amiens-Picardie - Hopital SUD
Hopital Saint-Louis (AP-HP) - Service Hematologie Senior
Hospices Civils de Lyon - Hopital Lyon Sud- Hematologie
CHU de Tours-Hopital Bretonneau-Centre Regional de cancerologie Henry Kaplan
Staedtisches Klinikum Braunschweig gGmbH
King's College Hospital
The Newcastle Hospitals NHS Foundation Trust
Oxford University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A

Arm B

Arm Description

MDS patients: PF-04449913 (Glasdegib) 100 mg + Azacitidine 75 mg/m2

AML patients: PF-04449913 (Glasdegib) 100 mg + Azacitidine 75 mg/m2

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Lead-in Cohort (LIC)

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred after initiation of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. Grades of AEs were defined by NCI CTCAE version 4.03.

Number of Participants With Serious Adverse Events (SAEs) in the LIC

An serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator. Grades of AEs were defined by NCI CTCAE version 4.03.

Number of Participants With Laboratory Abnormalities in the LIC

Laboratory parameters included: hematology parameters (activated partial thromboplastin time, hemoglobin, INR, lymphocyte count, neutrophil count, platelet count, white blood cell), chemistry parameters (alanine aminotransferase, aspartate aminotransferase, alkaline aminotransferase, blood bilirubin, CPK, creatinine, calcium, blood glucose, potassium, magnesium, sodium, albumin, phosphate). Grades of laboratory abnormalities were defined by NCI CTCAE version 4.03.

Percentage of Participants Achieving Complete Remission (CR) in the AML and MDS Cohorts

Percentage of participants achieving CR as defined by the 2017 European Leukemia Net (ELN) Response Criteria for all participants with AML and modified International Working Group (IWG) criteria (2006) for all participants with MDS in the expansion cohorts. For AML cohort, CR was defined as neutrophils ≥ 1 x 10^9/L, platelets ≥ 1 x 10^11/L, percentage of bone marrow blasts (BMB) <5% with no peripheral blasts and no blasts with Auer rods, no extramedullary disease (EMD), and transfusion independent. For MDS cohort, CR was defined as having responses of hemoglobin ≥11 g/dL, neutrophils ≥1 x 10^9/L, platelets ≥1 x 10^11/L, percentage of blasts = 0%, percentage of BMB≤5%, and normal maturation of all cell lines (note if has persistent dysplasia), and all responses must last at least 4 weeks.

Secondary Outcome Measures

Percentage of Participants Achieving Complete Remission (CR) + Partial Remission (PR) in the LIC

RR (Percentage of participants achieving CR+PR among all the enrolled and treated patients as defined by modified International Working Group (IWG) criteria (2006)) in the LIC. CR was defined as having responses of hemoglobin ≥11 g/dL, neutrophils ≥1 x 10^9/L, platelets ≥1 x 10^11/L, percentage of blasts = 0%, percentage of BMB≤5%, and normal maturation of all cell lines (note if has persistent dysplasia), and all responses must last at least 4 weeks. PR was defined as meeting all CR criteria if abnormal before treatment except BMB, percentage of BMB decreased by ≥50% but still >5% for at least 4 weeks.

Number of Participants With Efficacy Measures Other Than CR in the LIC

Number of participants with efficacy measures other than CR as defined by modified IWG criteria (2006) in LIC, including marrow CR(mCR), stable disease(SD), hematologic improvement(HI). CR: hemoglobin≥11 g/dL, neutrophils≥1 x 10^9/L, platelets≥1 x 10^11/L, percentage of blasts=0%, percentage of BMB≤5%, normal maturation of all cell lines (note if has persistent dysplasia), all responses last at least 4 weeks. mCR: BMB≤5% & decreased by≥50%. SD: failure to achieve PR, no evidence of progression. HI: erythroid response (pretreatment<11g/dL): hemoglobin increase by≥1.5 g/dL, relevant reduction of units of red blood cell transfusions by at least 4 transfusions/8 weeks compared to pretreatment transfusion number in previous 8 weeks; platelet response (pretreatment<1x10^11/L): increase of≥30x10^9/L if starting with >20x10^9/L, and increase from <20x10^9/L to >20x10^9/L and by at least 100%; neutrophil response (pretreatment<1x10^9/L): at least a 100% increase, absolute increase >0.5x10^9/L

Number of Participants With TEAEs in the AML and MDS Cohorts

Number of Participants With SAEs in the AML and MDS Cohorts

A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator. AEs were graded by NCI CTCAE version 4.03.

Number of Participants With Laboratory Abnormalities in the AML and MDS Cohorts

Laboratory parameters included: hematology parameters (activated partial thromboplastin time, hemoglobin, INR, lymphocyte count, neutrophil count, platelet count, white blood cell), chemistry parameters (alanine aminotransferase, aspartate aminotransferase, alkaline aminotransferase, blood bilirubin, CPK, creatinine, calcium, blood glucose, potassium, magnesium, sodium, albumin, phosphate). Laboratory abnormalities were graded by NCI CTCAE version 4.03.

Number of Participants With Disease-Specific Efficacy Measures in the AML Cohort

Number of participants with CR with partial hematologic recovery (CRh), CR with incomplete blood count recovery (CRi), partial remission (PR), stable disease (SD), and morphologic leukemia free state (MLFS). CRh: neutrophils>5x10^8/L, platelets>5x10^10/L, BMB<5%, no peripheral blasts, no blasts with Auer rods, no extramedullary disease (EMD), not qualifying for CR. CRi: neutrophils <1x10^9/L or platelets<1x10^11/L; BMB <5%, no peripheral blasts, no blasts with Auer rods; no EMD; neutrophils or platelets not recovered; not qualifying for CRh. PR: neutrophils ≥1x10^9/L; platelets ≥1x10^11/L; blasts decreased to 5-25% and ≥50% decrease from pretreatment; blasts≤5% if Auer rod positive. SD: ≥3 months of absence of CR without minimal residual disease (CRMRD-), CR, CRh, CRi, PR, and MLFS, criteria for PD not met. MLFS: neutrophils <1x10^9/L and platelets<1x10^11/L, BMB<5%, no blasts with Auer rods; no EMD; neutrophils and platelets not recovered; not qualifying for CRi

Number of Participants With Disease-Specific Efficacy Measures in the MDS Cohort

Number of participants with PR, marrow CR (mCR), SD, complete or partial cytogenetic response, and hematologic improvement (HI). PR: BMB >5% and decreased by ≥50% (at least 4 weeks), meeting all CR criteria if abnormal before treatment except BMB. mCR: BMB ≤5% and decreased by ≥50%. SD: failure to achieve PR, no evidence of progression. Complete or partial cytogenic response: disappearance of chromosomal abnormality without new ones, or ≥ 50% reduction of chromosomal abnormality. HI: erythroid response (pretreatment <11g/dL): hemoglobin increase by≥1.5 g/dL, relevant reduction of units of red blood cell transfusions by at least 4 transfusions/8 weeks compared to pretreatment transfusion number in previous 8 weeks; platelet response (pretreatment <1x10^11/L): increase of ≥30x10^9/L if starting with >20x10^9/L, and increase from <20x10^9/L to >20x10^9/L and by at least 100%; neutrophil response (pretreatment <1x10^9/L): at least a 100% increase, absolute increase >0.5x10^9/L.

Kaplan-Meier Estimate of Median Overall Survival (OS) in the AML and MDS Cohorts

Overall survival (OS) was defined as the time from date of first study treatment to date of death from any cause. Patients last known to be alive were to be censored at the date of last contact. OS was analyzed and displayed graphically for each expansion cohort separately using the Kaplan-Meier method. The median event time and corresponding two-sided 95%CI were provided for each cohort. OS was first analyzed when the primary endpoint of CR was analyzed in the respective expansion cohort.

Duration of CR in the AML and MDS Cohorts

Duration of CR was defined as the duration from date of first achieving CR to the date of disease progression (relapse) after CR, or death due to any cause. Participants last known to be alive who were free from disease progression or relapse after CR were censored at the date of the last assessment that verified their disease status. Duration of CR was analyzed using the Kaplan-Meier method. Disease progression was defined as: percentage of bone marrow blasts increased by ≥50% to >5% (for participants with <5% blasts at screening), >10% (for participants with 5-10% blasts at screening), >20% (for participants with 11-20% blasts at screening) or >30% (for participants with 21-30% blasts at screening), and with any of the following condition: at least 50% decrease from maximum remission/response in granulocytes or platelets; reduction in hemoglobin by ≥2 g/dL; transfusion dependence.

Time to CR in the AML and MDS Cohorts

Time to CR was defined for participants in the expansion cohorts who had achieved response on study as the time from date of the first dose of study drug to date of the first documentation of response. Time to CR was analyzed using the Kaplan-Meier method.

Maximum Plasma Concentration (Cmax) of Glasdegib Dosed in Combination With Azacitidine (C1D7) and When Dosed Alone (C1D15) in the Lead-in Cohort

Maximum plasma concentration of glasdegib dosed in combination with azacitidine (C1D7) and when dosed alone (C1D15) in the Lead-in Cohort was estimated using non-compartmental analysis.

Area Under the Plasma Concentration Curve From Time Zero to End of Dosing Interval (AUCtau) of Glasdegib Dosed in Combination With Azacitidine (C1D7) and When Dosed Alone (C1D15) in the Lead-in Cohort

Area under the plasma concentration curve from time zero to end of dosing interval (AUCtau) of glasdegib dosed in combination with azacitidine (C1D7) and when dosed alone (C1D15) in the Lead-in Cohort was estimated using non-compartmental analysis.

Time to First Occurrence of Maximum Plasma Concentration (Tmax) of Glasdegib Dosed in Combination With Azacitidine (C1D7) and When Dosed Alone (C1D15) in the Lead-in Cohort

Time to first occurrence of maximum plasma concentration of glasdegib dosed in combination with azacitidine (C1D7) and when dosed alone (C1D15) in the Lead-in Cohort was estimated using non-compartmental analysis.

Maximum Plasma Concentration (Cmax) of Azacitidine Dosed in Combination With Glasdegib (C1D7) and When Dosed Alone (C1D1) in the Lead-in Cohort

Maximum plasma concentration of azacitidine dosed in combination with glasdegib (C1D7) and when dosed alone (C1D1) in the Lead-in Cohort was estimated using non-compartmental analysis.

Area Under the Plasma Concentration Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Azacitidine Dosed in Combination With Glasdegib (C1D7) and When Dosed Alone (C1D1) in the Lead-in Cohort

Area under the plasma concentration curve from time zero to extrapolated infinite time (AUCinf) of azacitidine dosed in combination with glasdegib (C1D7) and when dosed alone (C1D1) in the Lead-in Cohort was estimated using non-compartmental analysis.

Tmax of Azacitidine Dosed in Combination With Glasdegib (C1D7) and When Dosed Alone (C1D1) in the Lead-in Cohort

Time to first occurrence of maximum plasma concentration of azacitidine dosed in combination with glasdegib (C1D7) and when dosed alone (C1D1) in the Lead-in Cohort was estimated using non-compartmental analysis.

Trough Plasma Concentration (Ctrough) of Glasdegib on C1D15 and C2D1 in the AML and MDS Cohorts

Trough plasma concentration was defined as the estimated lowest concentration before next dose administration.

Number of Participants Meeting Categorical Criteria of QTcF Values in LIC, AML and MDS Cohorts

Number of participants that met categorical criteria of QTcF values in LIC, AML and MDS cohorts

Full Information

NCT ID

NCT02367456

First Posted

February 13, 2015

Last Updated

May 26, 2022

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02367456

Brief Title

A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients

Acronym

BRIGHT 1012

Official Title

An Open-label Phase 1b Study of PF-04449913 (Glasdegib) in Combination With Azacitidine in Patients With Previously Untreated Higher-Risk Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

April 28, 2015 (Actual)

Primary Completion Date

January 29, 2020 (Actual)

Study Completion Date

March 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This multi center open label Phase 1b study is designed to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of glasdegib (PF-04449913) when combined with azacitidine in patients with previously untreated Higher Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). This clinical study includes two components: (a) a safety lead in cohort (LIC) and (b) an expansion phase with an AML cohort and an MDS cohort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myelodysplastic Syndrome, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia

Keywords

MDS, AML, CMML

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

MDS patients: PF-04449913 (Glasdegib) 100 mg + Azacitidine 75 mg/m2

Arm Title

Arm B

Arm Type

Experimental

Arm Description

AML patients: PF-04449913 (Glasdegib) 100 mg + Azacitidine 75 mg/m2

Intervention Type

Drug

Intervention Name(s)

PF-04449913 (Glasdegib)

Intervention Description

Daily dose of PF-04449913 100mg tablet in a continuous regimen of 28 day cycles

Intervention Type

Drug

Intervention Name(s)

Azacitidine

Intervention Description

75mg/m2 on Days 1-7 (+/- 3 days for each dose) of a 28 day cycle

Primary Outcome Measure Information:

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Lead-in Cohort (LIC)

Description

Time Frame

Cycle 1 Day 1 up to 28 days after last dose of study drug or beginning of new anti-cancer therapy (assessed up to 16 months)

Title

Number of Participants With Serious Adverse Events (SAEs) in the LIC

Description

Time Frame

Cycle 1 Day 1 up to 28 days after last dose of study drug or beginning of new anti-cancer therapy (assessed up to 16 months)

Title

Number of Participants With Laboratory Abnormalities in the LIC

Description

Time Frame

Cycle 1 Day 1 to last follow up visit (at least 28 days after discontinuation of treatment) (assessed up to 17 months)

Title

Percentage of Participants Achieving Complete Remission (CR) in the AML and MDS Cohorts

Description

Time Frame

Cycle 1 Day 1 to End of Treatment (EoT) visit (within 14 days after last dose) (assessed up to 22 months)

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving Complete Remission (CR) + Partial Remission (PR) in the LIC

Description

Time Frame

Cycle 1 Day 1 to last follow up visit (at least 28 days after discontinuation of treatment) (assessed up to 18 months)

Title

Number of Participants With Efficacy Measures Other Than CR in the LIC

Description

Time Frame

Cycle 1 Day 1 to last follow up visit (at least 28 days after discontinuation of treatment) (assessed up to 18 months)

Title

Number of Participants With TEAEs in the AML and MDS Cohorts

Description

Time Frame

Cycle 1 Day 1 to EoT visit (within 14 days after last dose) (assessed up to 24 months)

Title

Number of Participants With SAEs in the AML and MDS Cohorts

Description

Time Frame

Cycle 1 Day 1 to EoT visit (within 14 days after last dose) (assessed up to 24 months)

Title

Number of Participants With Laboratory Abnormalities in the AML and MDS Cohorts

Description

Laboratory parameters included: hematology parameters (activated partial thromboplastin time, hemoglobin, INR, lymphocyte count, neutrophil count, platelet count, white blood cell), chemistry parameters (alanine aminotransferase, aspartate aminotransferase, alkaline aminotransferase, blood bilirubin, CPK, creatinine, calcium, blood glucose, potassium, magnesium, sodium, albumin, phosphate). Laboratory abnormalities were graded by NCI CTCAE version 4.03.

Time Frame

Cycle 1 Day 1 to EoT visit (within 14 days after last dose) (assessed up to 24 months)

Title

Number of Participants With Disease-Specific Efficacy Measures in the AML Cohort

Description

Time Frame

Cycle 1 Day 1 to EoT visit (within 14 days after last dose) (assessed up to 20 months)

Title

Number of Participants With Disease-Specific Efficacy Measures in the MDS Cohort

Description

Time Frame

Cycle 1 Day 1 to EoT visit (within 14 days after last dose) (assessed up to 22 months)

Title

Kaplan-Meier Estimate of Median Overall Survival (OS) in the AML and MDS Cohorts

Description

Time Frame

Cycle 1 Day 1 to date of death from any cause (assessed up to 24 months)

Title

Duration of CR in the AML and MDS Cohorts

Description

Time Frame

Cycle 1 Day 1 to EoT visit (within 14 days after last dose) (assessed up to 24 months)

Title

Time to CR in the AML and MDS Cohorts

Description

Time Frame

Cycle 1 Day 1 to EoT visit (within 14 days after last dose) (assessed up to 24 months)

Title

Maximum Plasma Concentration (Cmax) of Glasdegib Dosed in Combination With Azacitidine (C1D7) and When Dosed Alone (C1D15) in the Lead-in Cohort

Description

Maximum plasma concentration of glasdegib dosed in combination with azacitidine (C1D7) and when dosed alone (C1D15) in the Lead-in Cohort was estimated using non-compartmental analysis.

Time Frame

Pre-dose and 0.25, 1, 4, 6, 24 hours post-dose on Cycle 1 Day 7 and Day 15

Title

Description

Time Frame

Pre-dose and 0.25, 1, 4, 6, 24 hours post-dose on Cycle 1 Day 7 and Day 15

Title

Time to First Occurrence of Maximum Plasma Concentration (Tmax) of Glasdegib Dosed in Combination With Azacitidine (C1D7) and When Dosed Alone (C1D15) in the Lead-in Cohort

Description

Time Frame

Pre-dose and 0.25, 1, 4, 6, 24 hours post-dose on Cycle 1 Day 7 and Day 15

Title

Maximum Plasma Concentration (Cmax) of Azacitidine Dosed in Combination With Glasdegib (C1D7) and When Dosed Alone (C1D1) in the Lead-in Cohort

Description

Maximum plasma concentration of azacitidine dosed in combination with glasdegib (C1D7) and when dosed alone (C1D1) in the Lead-in Cohort was estimated using non-compartmental analysis.

Time Frame

0.25, 0.5, 1, 2, 6 hours post-dose on Cycle 1 Day 1; pre-dose and 0.25, 0.5, 1, 2, 6 hours post-dose on Cycle 1 Day 7.

Title

Description

Time Frame

0.25, 0.5, 1, 2, 6 hours post-dose on Cycle 1 Day 1; pre-dose and 0.25, 0.5, 1, 2, 6 hours post-dose on Cycle 1 Day 7.

Title

Tmax of Azacitidine Dosed in Combination With Glasdegib (C1D7) and When Dosed Alone (C1D1) in the Lead-in Cohort

Description

Time Frame

0.25, 0.5, 1, 2, 6 hours post-dose on Cycle 1 Day 1; pre-dose and 0.25, 0.5, 1, 2, 6 hours post-dose on Cycle 1 Day 7.

Title

Trough Plasma Concentration (Ctrough) of Glasdegib on C1D15 and C2D1 in the AML and MDS Cohorts

Description

Trough plasma concentration was defined as the estimated lowest concentration before next dose administration.

Time Frame

Pre-dose and 1 and 4 hours post-dose on Cycle 1 Day 15 and Cycle 2 Day 1.

Title

Number of Participants Meeting Categorical Criteria of QTcF Values in LIC, AML and MDS Cohorts

Description

Number of participants that met categorical criteria of QTcF values in LIC, AML and MDS cohorts

Time Frame

Cycle 1 Day 1 to EoT visit (assessed up to 16 months in the LIC cohort and 24 months in the AML and MDS cohorts)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Patients must have previously untreated MDS, AML, or CMML according to the WHO 2016 classification. MDS patients must have Intermediate (>3 to 4.5 points), High Risk (>4.5 - 6) or Very High Risk (>6 points) disease according to the Revised International Prognostic Scoring System 2012 (IPSS-R). Clinical indication for treatment with azacitidine for MDS or AML. Exclusion criteria: Patients with AML who are candidates for standard induction chemotherapy as first line treatment. Patients with known active CNS leukemia. Prior treatment with a smoothened inhibitor (SMOi) and/or hypomethylating agent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

University of Alabama at Birmingham the Kirklin Clinic

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35249

Country

United States

Facility Name

UC San Diego Moores Cancer Center

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Smilow Cancer Center at Yale New Haven Hospital

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Montefiore Einstein Center for Cancer

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Facility Name

Stony Brook University Hospital Cancer Center

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

Facility Name

Stony Brook University

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

Facility Name

Duke University Health System: Adult Bone Marrow Transplant Clinic

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

Duke University Health System, Duke University Hospital

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Duke University Health System

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Investigational Chemotherapy Service

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Cleveland Clinic Taussig Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Henry-Joyce Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Vanderbilt - Ingram Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Huntsman Cancer Hospital

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Facility Name

Huntsman Cancer Institute

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Facility Name

Seattle Cancer Care Alliance (SCCA)

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

University of Washington Medical Center (UWMC)

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Facility Name

Ziekenhuis Netwerk Antwerpen - Campus Stuivenberg

City

Antwerpen

ZIP/Postal Code

2060

Country

Belgium

Facility Name

UZ Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Tom Baker Cancer Center

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

University Of Alberta Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

CHU d'Amiens-Picardie - Hopital SUD

City

Amiens cedex 01

ZIP/Postal Code

80054

Country

France

Facility Name

Hopital Saint-Louis (AP-HP) - Service Hematologie Senior

City

Paris CEDEX 10

ZIP/Postal Code

75475

Country

France

Facility Name

Hospices Civils de Lyon - Hopital Lyon Sud- Hematologie

City

Pierre Benite Cedex

ZIP/Postal Code

69495

Country

France

Facility Name

CHU de Tours-Hopital Bretonneau-Centre Regional de cancerologie Henry Kaplan

City

Tours Cedex 01

ZIP/Postal Code

37044

Country

France

Facility Name

Staedtisches Klinikum Braunschweig gGmbH

City

Braunschweig

ZIP/Postal Code

38114

Country

Germany

Facility Name

King's College Hospital

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

The Newcastle Hospitals NHS Foundation Trust

City

Newcastle upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Oxford University Hospitals NHS Foundation Trust

City

Oxford

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Citations:

PubMed Identifier

35488900

Citation

Sekeres MA, Schuster M, Joris M, Krauter J, Maertens J, Breems D, Gyan E, Kovacsovics T, Verma A, Vyas P, Wang ES, Ching K, O'Brien T, Gallo Stampino C, Ma WW, Kudla A, Chan G, Zeidan AM. A phase 1b study of glasdegib + azacitidine in patients with untreated acute myeloid leukemia and higher-risk myelodysplastic syndromes. Ann Hematol. 2022 Aug;101(8):1689-1701. doi: 10.1007/s00277-022-04853-4. Epub 2022 Apr 30.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371012&StudyName=A%20STUDY%20OF%20PF%2004449913%20IN%20COMBINATION%20WITH%20AZACITIDINE%20IN%20PATIENTS%20WITH%20PREVIOUSLY%20UNTREATED%20INTERMEDIATE%202%20OR%20HIGH%20RISK%20MYELODYSPLASTIC

Description

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Learn more about this trial

A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients

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