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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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 three parts; a dose escalation (Part 1), an intra-patient dose titration (Part 2), and an expansion (Part 3).

Official Title

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

Keywords

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

Eligibility

For people ages 18 years and up

Key Inclusion Criteria:

  • Confirmed diagnosis of advanced malignancy:
  • Treatment Group A (TGA): Part 1 and Part 2: Any advanced solid tumor or lymphoma;

Part 3: Histologically confirmed disease in specific solid tumors and lymphomas

  • Treatment Group B (TGB): Acute Leukemia (Part 3 - 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 in Parts 1 and 2 dose escalation and titration, and 0, 1, 2 in Part 3 dose expansion

Key Exclusion Criteria:

  • 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
  • < 5 half-lives or 14 days, whichever is longer, for any investigational agent(for any indication)
  • < 28 days for any antibodies or biological therapies
  • < 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
  • Type 1 diabetes or uncontrolled Type 2 diabetes
  • Any sign of clinically significant bleeding

Locations

  • University of California, San Francisco, Medical Center at Mount Zion
    San Francisco, California, 94115, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California, 90048, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT02431260
Phase
Phase 1/2
Lead Scientist
Pamela Munster
Study Type
Interventional
Last Updated
October 3, 2017