Clinical trial · Interventional
An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054329 in Subjects With Advanced Malignancies
NCT02431260CI-TRIAL-00039081terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): As of 31 JAN 2018, the study was terminated by the sponsor due to PK variability.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors and Hematologic Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INCB054329 Monotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- INCB054329 Monotherapy
- interventionNames
- Drug: INCB054329 Monotherapy
Primary outcomes (1)
- measure
- Number of Participants With a Treatment-emergent Adverse Event (TEAE)
- timeFrame
- up to 30 days
- description
- TEAE is defined as an adverse event reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Secondary outcomes (10)
- measure
- Maximum Plasma Concentration (Cmax) Analysis of INCB054329
- timeFrame
- Summary of steady-state PK parameters by dosing regimen at Day 15
- description
- Cmax is defined as the maximum observed serum concentration measured at steady state (Day 15). Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDFalchook G, Rosen S, LoRusso P, Watts J, Gupta S, Coombs CC, Talpaz M, Kurzrock R, Mita M, Cassaday R, Harb W, Peguero J, Smith DC, Piha-Paul SA, Szmulewitz R, Noel MS, Yeleswaram S, Liu P, Switzky J, Zhou G, Zheng F, Mehta A. Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies. Clin Cancer Res. 2020 Mar 15;26(6):1247-1257. doi: 10.1158/1078-0432.CCR-18-4071. Epub 2019 Sep 16. PMID 31527168