INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
第1/2相
実施中（募集終了）
NCT04455841
| 対象疾患 | Anemia, Post-essential Thrombocythemia Myelofibrosis, Post-polycythemia Vera Myelofibrosis |
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| 相 | 第1/2相 |
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| スポンサー | Incyte Corporation |
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| ステータス | 実施中（募集終了） |
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| 参加者数 | 84 名 |
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| 介入（薬剤） | INCB000928, ruxolitinib |
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| 開始日 | 2021年3月19日 |
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| 完了日 | 2025年4月1日 |
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| 結果公開日 | 2026年5月12日 |
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概要
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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BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。