An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies
This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment groups also had an intra-patient dose titration (Part 2).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jun 14, 2019 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Incyte Corporation
- Interventions being studied
- Drug: INCB054329 Monotherapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Cedars-Sinai Medical CenterLos Angeles, California
- University of California, San Francisco, Medical Center at Mount ZionSan Francisco, California
- Sarah Cannon Research Institute Research CenterDenver, Colorado
- Northwestern Memorial HospitalChicago, Illinois
- The University of Chicago Medical CenterChicago, Illinois
- Horizon Oncology CenterLafayette, Indiana
- John HopkinsBaltimore, Maryland
- University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan
- Washington University School of Medicine in St. LouisSt Louis, Missouri
- Vanderbilt University Medical CenterNashville, Tennessee
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- Seattle Cancer Care AllianceSeattle, Washington
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 14, 2019. Always confirm current availability with the study team.