Last updated on July 2018

A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes


Brief description of study

CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects with relapsed or refractory acute myeloid leukemia and relapsed or refractory high-risk myelodysplastic syndrome.

Detailed Study Description

Study CC-90009-AML-001 is an open-label, Phase 1, dose escalation and expansion, first-in-human clinical study of CC-90009 in subjects with relapsed or refractory acute myeloid leukemia (AML) and relapsed or refractory high-risk myelodysplastic syndrome.

The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-90009 in relapsed and refractory AML. The expansion part, (Part B), will further evaluate the safety and efficacy of CC-90009 administered at or below the maximum tolerated dose (MTD) in selected expansion cohorts of one or more dosing regimens in order to determine the recommended Phase 2 dose (RP2D) for subjects with relapsed or refractory AML and relapsed or refractory high-risk myelodysplastic syndrome.

Clinical Study Identifier: NCT02848001

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Yale Cancer Center
New Haven, CT United States
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Northwestern Memorial
Chicago, IL United States
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Dana Farber Cancer Institute
Boston, MA United States
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Washington University Siteman Cancer Center
Saint Louis, MO United States
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Hackensack University Medical Center
Hackensack, NJ United States
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Princess Margaret Hospital University Health Network
Toronto, ON Canada
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Institut Paoli Calmettes
Marseille Cedex 9, France
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Institut Gustave Roussy Faculte de Medecine Paris Sud Service de pneumologie
Villejuif, France
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Spedali Civili Di Brescia
Brescia, Italy
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A.O. Ospedale Ca Granda - Niguarda
Milano, Italy
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Beatson West of Scotland Cancer Centre
Glasgow Scotland, United Kingdom
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The Churchill Hospital
Oxford, United Kingdom
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City of Hope
Duarte, CA United States
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Haukeland University Hospital
Bergen, Norway
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Oslo University Hospital, Rikshospitalet HF
Oslo, Norway
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H Clinic I Provincial
Barcelona, Spain
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Hospital Clinico Universitario de Salamanca
Salamanca, Spain
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Memorial Sloan Kettering Cancer Center
New York, NY United States
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