INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
1/2期
进行中（已停止招募）
NCT04455841
| 适应症 | Anemia, Post-essential Thrombocythemia Myelofibrosis, Post-polycythemia Vera Myelofibrosis |
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| 分期 | 1/2期 |
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| 申办方 | Incyte Corporation |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 84 人 |
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| 干预（药物） | INCB000928, ruxolitinib |
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| 开始日期 | 2021年3月19日 |
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| 完成日期 | 2025年4月1日 |
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| 结果公布日 | 2026年5月12日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。