Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Фаза 1 – тестване на безопасността при малка група хора
Заболявания:
Myeloproliferative Neoplasms
Спонсор: Incyte Corporation
Налично на:
БГ
Обобщение
This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy.
Кой може да участва
Inclusion Criteria:
* Life expectancy \> 6 months.
* Willingness to undergo a pretreatment and limited on-study BM biopsies and aspirates (as appropriate to disease).
* Participants with MF, PV and ET as defined in the protocol.
Exclusion Criteria:
* Presence of any hematological malignancy other than MF, PV, or ET.
* Malignancy within the last 3 years prior to enrollment.
* Acute or chronic HBV, Active HCV or known HIV or tuberculosis infection.
* Clinically significant or uncontrolled cardiac disease.
* Has undergone any prior allogeneic stem-cell transplantation or such transplantation is planned in the next 6 months.
* Laboratory values outside the Protocol-defined ranges.
* Prior history of major bleeding or thrombosis within the last 3 months prior to study enrollment.
* Presence of chronic or current active infectious disease requiring systemic treatment.
* Treatment with an MPN-directed therapy (approved or investigational) within the per protocol threshold before the administration of study drug.
* Prior radiation therapy within 28 days before the first dose of study treatment.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Места на провеждане
9
Австралия (1)
Concord General Repatriation Hospital
Concord , New South Wales
NOT_YET_RECRUITING
Белгия (1)
Centre Hospitalier Universitaire (Chu) de Liege
Liège
NOT_YET_RECRUITING
Канада (1)
Hopital Maisonneuve-Rosemont, Montreal, Qc
Montreal , Quebec
NOT_YET_RECRUITING
Франция (1)
Institut Bergonie
Bordeaux
NOT_YET_RECRUITING
Германия (1)
University Medical Center Rwth Aachen
Aachen
NOT_YET_RECRUITING
Италия (1)
Aou Policlinico S. Orsola-Malpighi
Bologna
NOT_YET_RECRUITING
Испания (1)
Hospital Universitari Germans Trias I Pujol
Badalona
NOT_YET_RECRUITING
Великобритания (1)
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust