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).
Checked against the public recordLast updated Jun 14, 2019 · Source: ClinicalTrials.gov
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
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
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.