Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML

Sponsor
Pfizer (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04842604
Collaborator
(none)
15
18
1
19
0.8
0

Study Details

Study Description

Brief Summary

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A MULTI-CENTER CONTINUATION STUDY EVALUATING AZACITIDINE WITH OR WITHOUT GLASDEGIB (PF-04449913) IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA, MYELODYSPLASTIC SYNDROME OR CHRONIC MYELOMONOCYTIC LEUKEMIA
Actual Study Start Date :
May 17, 2021
Anticipated Primary Completion Date :
Dec 16, 2022
Anticipated Study Completion Date :
Dec 16, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Participants from B1371019 and B1371012

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.

Drug: Glasdegib
25 mg or 100 mg tablet
Other Names:
  • PF-04449913
  • Drug: Azacitidine
    100 mg/vial powder for 25 mg/mL suspension for injection

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with treatment related adverse events (TEAE) [Baseline through 28 days after last dose (up to approximately 20 months)]

    2. Number of participants with serious adverse events (SAE) [Baseline through 28 days after last dose (up to approximately 20 months)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Any participant who continues to demonstrate clinical benefit (as determined by the Principal Investigator) from study treatment with azacitidine with or without glasdegib in this Study or from Study B1371012.

    • Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

    Exclusion Criteria:
    • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

    • Female participants who are pregnant or breastfeeding (if continuing to receive study intervention);

    • Participant has been withdrawn from Study B1371019 and Study B1371012 for any reason (including INT cohort participants required to end study treatment)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU Salzburg Austria 5020
    2 Uniklinikum Salzburg, Landeskrankenhaus Salzburg Salzburg Austria 5020
    3 Health Sciences Centre Winnipeg Manitoba Canada R3A 1R9
    4 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    5 Ustavni lekarna Ostrava - Poruba Czechia 708 52
    6 Klinika hematoonkologie Ostrava-Poruba Czechia 708 52
    7 CHU de Nantes Nantes cedex 1 France 44093
    8 CHU de Nantes Hotel Dieu Nantes cedex France 44093
    9 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek Debrecen Hungary 4032
    10 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika Debrecen Hungary 4032
    11 AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia Torrette Di Ancona Ancona Italy 60126
    12 SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi Torette Di Ancona AN Italy 60126
    13 University of Fukui Hospital Yoshida-gun Fukui Japan 910-1193
    14 Osaka City University Hospital Osaka-City Osaka Japan 545-8586
    15 Instituto Nacional de Cancerología México MÉX Mexico 14080
    16 WWCOiT im. M. Kopemlka w Lodzl Lodz Poland 93-513
    17 Hospital Universitari i Politecnic La Fe Valencia Spain 46026
    18 The Royal Marsden NHS Foundation Trust Sutton Surry United Kingdom SM2 5PT

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT04842604
    Other Study ID Numbers:
    • B1371019 Open Label Extension
    • 2017-002822-19
    First Posted:
    Apr 13, 2021
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 18, 2022