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for people ages 18 years and up
at San Francisco, California and other locations
study started
estimated completion:
Principal Investigator



This is a study of INCB054329 given to patients with advanced malignancies that will be conducted in three treatment groups. Each treatment group will have two parts; a dose escalation (Part 1) and an expansion (Part 2).

Official Title

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054329 in Subjects With Advanced Malignancies


Advanced Cancer solid tumor lymphoma BET bromodomain inhibitor BRD Diffuse large B-cell lymphoma (DLBCL) Burkitt's lymphoma c-MYC colorectal cancer Non-small cell lung cancer Pancreatic adenocarcinoma castration-resistant prostate cancer breast cancer NUT midline carcinoma leukemia acute myeloid leukemia (AML) atypical chronic myeloid leukemia (aCML) myelodysplastic syndrome (MDS) myeloproliferative neoplasms myelofibrosis (MF) multiple myeloma (MM) CMML MDS/MPN-U RARS-T


You can join if…

Open to people ages 18 years and up

  • Confirmed diagnosis of advanced malignancy:
  • Treatment Group A (TGA): Part 1:Any advanced solid tumor or lymphoma; Part 2:Histologically confirmed disease in specific tumor types
  • Treatment Group B (TGB): Leukemia (Part 2 - acute myeloid leukemia [AML] only),myelodysplastic syndrome (MDS), myelodysplastic /myeloproliferative neoplasms(MDS/MPN) and myelofibrosis (MF)
  • Treatment Group C (TGC): Multiple myeloma
  • Progressed following at least 1 line of prior therapy and there is no further approved therapy available that has been demonstrated to prolong survival (including subjects who are intolerant to the approved therapy)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You CAN'T join if...

  • Inadequate hematopoietic, liver, endocrine or renal function
  • Receipt of anticancer medications or investigational drugs within the following interval before the first administration of study drug:
  • < 6 weeks for mitomycin-C or nitrosoureas
  • < 28 days for any investigational agent (for any indication)
  • < 5 half-lives for all other anticancer medications, or sponsor approval
  • Prior radiotherapy within 2 weeks prior to first dose of study drug
  • Untreated brain or central nervous system (CNS) metastases


  • San Francisco, California, USA
  • Los Angeles, California, USA


accepting new patients
Start Date
Completion Date
Incyte Corporation
Phase 1/2
Lead Scientist
Pamela Munster
Study Type
Last Updated
August 2016
I'm interested in this study!