INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
1/2상
진행 중(모집 완료)
NCT04455841
| 대상 질환 | Anemia, Post-essential Thrombocythemia Myelofibrosis, Post-polycythemia Vera Myelofibrosis |
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| 임상 단계 | 1/2상 |
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| 스폰서 | Incyte Corporation |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 84 명 |
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| 중재(약물) | INCB000928, ruxolitinib |
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| 시작일 | 2021년 3월 19일 |
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| 완료일 | 2025년 4월 1일 |
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| 결과 공개일 | 2026년 5월 12일 |
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요약
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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BENITIONS에서 보기
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