INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
Фаза 1/2
Идёт, набор закрыт
NCT04455841
| Заболевание | Anemia, Post-essential Thrombocythemia Myelofibrosis, Post-polycythemia Vera Myelofibrosis |
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| Фаза | Фаза 1/2 |
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| Спонсор | Incyte Corporation |
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| Статус | Идёт, набор закрыт |
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| Участники | 84 участн. |
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| Вмешательство | INCB000928, ruxolitinib |
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| Дата начала | 19.03.2021 |
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| Дата завершения | 1.04.2025 |
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| Публикация результатов | 12.05.2026 |
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Кратко
This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and expansion.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-emergent Serious Adverse Event (SAE)
up to approximately 4 years · Participants
| Zilurgisertib Monotherapy 50 mg QD | 4 Participants |
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| Zilurgisertib Monotherapy 100 mg QD | 4 Participants |
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| Zilurgisertib Monotherapy 200 mg QD | 6 Participants |
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| Zilurgisertib Monotherapy 400 mg QD | 11 Participants |
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| Zilurgisertib Monotherapy 600 mg QD | 4 Participants |
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| Zilurgisertib Monotherapy 300 mg BID | 3 Participants |
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Number of Participants With Any ≥Grade 3 TEAE and Any Treatment-emergent SAE
up to approximately 4 years · Participants
| Zilurgisertib Monotherapy 50 mg QD | 1 Participants |
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| Zilurgisertib Monotherapy 100 mg QD | 0 Participants |
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| Zilurgisertib Monotherapy 200 mg QD | 5 Participants |
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| Zilurgisertib Monotherapy 400 mg QD | 3 Participants |
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| Zilurgisertib Monotherapy 600 mg QD | 2 Participants |
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| Zilurgisertib Monotherapy 300 mg BID | 2 Participants |
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Number of Participants With Dose-limiting Toxicities (DLTs)
from Cycle 1 Day 1 to Cycle 1 Day 28 · Participants
| Zilurgisertib Monotherapy 50 mg QD | 0 Participants |
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| Zilurgisertib Monotherapy 100 mg QD | 0 Participants |
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| Zilurgisertib Monotherapy 200 mg QD | 0 Participants |
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| Zilurgisertib Monotherapy 400 mg QD | 0 Participants |
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| Zilurgisertib Monotherapy 600 mg QD | 0 Participants |
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| Zilurgisertib Monotherapy 300 mg BID | 0 Participants |
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