Clinical trial · Interventional
Belinostat in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
A Phase I/II Study of PXD101 in Patients With Unresectable Hepatocellular Carcinoma With Pharmacokinetic and Pharmacodynamic Evaluation
NCT00321594CI-TRIAL-00030217completedPhase 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
Summary
Brief summary (as posted)
This phase I/II trial is studying the side effects and best dose of belinostat and to see how well it works in treating patients with liver cancer that cannot be removed by surgery. Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Primary Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | ALIAS | 0.90 |
| Advanced Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Localized Unresectable Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Recurrent Adult Primary Liver Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| belinostat | Drug | Belinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (enzyme inhibitor therapy)
- description
- Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: belinostat
Primary outcomes (2)
- measure
- Dose-limiting Toxicities (DLT) and Maximum Tolerated Dose (MTD) of Belinostat in Patients With Inoperable HCC (Phase I)
- timeFrame
- Course 1
- description
- DLT is defined as any grade 4 hematological toxicity and any grade 3 or 4 non hematological toxicity during cycle 1, excluding alopecia. Specifically, grade 3 nausea, vomiting, or diarrhea that does not respond to therapy is considered dose-limiting. Also, delays in treatment greater than 2 weeks are also dose-limiting. MTD is defined as the dose below which \>= 2 of 3 or \>= 2 of 6 patients experience DLT. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed hepatocellular carcinoma that is not amenable to curative resection * Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with MRI or spiral CT scan * No known brain metastases * No clinical ascites or encephalopathy * Life expectancy \> 12 weeks * ECOG performance status (PS) 0-2 or Karnofsky PS 60-100% * WBC ≥ 3,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.7 mg/dL * Albumin ≥ 2.8 mg/dL * ALT ≤ 5.0 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 6 times ULN * Prothrombin time ≤ 4 sec above ULN * Creatinine ≤ 1.6 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients use effective contraception * No Child's-Pugh's grading Class C hepatic impairment * No history of allergic reaction attributed to compounds of similar chemical or biologic composition to PXD101 * No marked baseline prolongation of QT/QTc interval, including the following: * Repeated demonstration of a QTc interval \> 500 msec * Long QT Syndrome * No ongoing or active infection * No significant cardiovascular disease, including any of the following: * Unstable angina pectoris * Uncontrolled hypertension * Congestive heart failure related to primary cardiac disease * Condition requiring anti-arrhythmic therapy * Ischemic or severe valvular heart disease * Myocardial infarction within the past 6 months * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered * More than 4 weeks since prior radiotherapy and recovered * At least 2 weeks since prior valproic acid * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent participation in another investigational study * No other concurrent investigational agents * No other concurrent anticancer therapy * No concurrent use of any of the following: * Disopyramide * Dofetilide * Ibutilide * Procainamide * Quinidine * Sotalol * Bepridil * Amiodarone * Arsenic trioxide * Cisapride * Calcium channel blockers (e.g., lidoflazine) * Clarithromycin * Erythromycin * Halofantrine * Pentamidine * Sparfloxacin * Domperidone * Droperidol * Chlorpromazine * Haloperidol * Mesoridazine * Thioridazine * Pimozide * Methadone
References
Publications (2)
- DERIVEDYeo W, Chan SL, Mo FK, Chu CM, Hui JW, Tong JH, Chan AW, Koh J, Hui EP, Loong H, Lee K, Li L, Ma B, To KF, Yu SC. Phase I/II study of temsirolimus for patients with unresectable Hepatocellular Carcinoma (HCC)- a correlative study to explore potential biomarkers for response. BMC Cancer. 2015 May 12;15:395. doi: 10.1186/s12885-015-1334-6. PMID 25962426
- DERIVEDWang LZ, Ramirez J, Yeo W, Chan MY, Thuya WL, Lau JY, Wan SC, Wong AL, Zee YK, Lim R, Lee SC, Ho PC, Lee HS, Chan A, Ansher S, Ratain MJ, Goh BC. Glucuronidation by UGT1A1 is the dominant pathway of the metabolic disposition of belinostat in liver cancer patients. PLoS One. 2013;8(1):e54522. doi: 10.1371/journal.pone.0054522. Epub 2013 Jan 30. PMID 23382909