Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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:
Drug: Azacitidine
100 mg/vial powder for 25 mg/mL suspension for injection
|
Outcome Measures
Primary Outcome Measures
- Number of participants with treatment related adverse events (TEAE) [Baseline through 28 days after last dose (up to approximately 20 months)]
- Number of participants with serious adverse events (SAE) [Baseline through 28 days after last dose (up to approximately 20 months)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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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:
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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.
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Female participants who are pregnant or breastfeeding (if continuing to receive study intervention);
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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 | |
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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.- B1371019 Open Label Extension
- 2017-002822-19