Clinical trial · Interventional
To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment.
An Open-label, Nonrandomized, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Belinostat in Patients With Relapsed/Refractory Solid Tumors or Hematological Malignancies Who Have Mild, Moderate, and Severe Renal Impairment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Close out study w/o Cohort D; Severe Impairment (eGFR=15 to \<30mL/min/1.73m²)
Summary
Brief summary (as posted)
A phase I, open-label, nonrandomized study to determine the PK profile of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies in patients with renal impairment. Eligible patients will be assigned to 1 of 4 cohorts (A, B, C or D) based on their level of renal function (normal, mild, moderate, or severe renal impairment) and receive belinostat dose A for normal or mild renal impairment, and dose B for moderate or severe renal impairment.
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 |
|---|---|---|---|
| Relapsed/Refractory Solid Tumors/Hematological Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Belinostat | Drug | Belinostat | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- Normal Renal function, Belinostat IV, Dose A
- interventionNames
- Drug: Belinostat
- type
- EXPERIMENTAL
- label
- Cohort B
- description
- Mild Impairment, Belinostat IV, Dose A
- interventionNames
- Drug: Belinostat
- type
- EXPERIMENTAL
- label
- Cohort C
- description
- Moderate Impairment, Belinostat IV, Dose B
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient is diagnosed with advanced solid tumors or advanced hematological malignancy that is relapsed/refractory, for which no standard salvage therapy exists. 2. Patient must have received at least 1 prior therapy for the current malignancy and has recovered from any toxicity of the prior therapy at screening. 3. Patient has either normal or impaired renal functions. 4. Patient has adequate hematological and hepatic functions. Exclusion Criteria: 1. Patient has acute or progressive renal impairment related to disease or any other cause (eg, toxicity, obstructive uropathy due to retroperitoneal disease, proteinuria, nephrotic syndrome), or requires dialysis. 2. Patient has acute HBV or HCV 3. Patient has known human immunodeficiency virus (HIV) positive diagnosis. 4. Patient has had previous exposure to belinostat.
References
Publications (0)
Data not yet available