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
4 other identifiers
interventional
54
2 countries
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2006
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 2, 2006
CompletedFirst Posted
Study publicly available on registry
May 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
September 26, 2017
CompletedNovember 6, 2017
October 1, 2017
4.3 years
May 2, 2006
March 27, 2017
October 3, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Dose-limiting Toxicities (DLT) and Maximum Tolerated Dose (MTD) of Belinostat in Patients With Inoperable HCC (Phase I)
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.
Course 1
Tumor Response in Patients With Inoperable HCC Using Belinostat (Phase II)
Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The 95% confidence intervals should be provided.
Every 2 courses (approximately 6 weeks)
Study Arms (1)
Treatment (enzyme inhibitor therapy)
EXPERIMENTALPatients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +50 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Cancer Therapeutics Research Group
Singapore, 119074, Singapore
Related Publications (2)
Yeo 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: 25962426DERIVEDWang 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: 23382909DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professor Winnie Yeo
- Organization
- Department of Clinical Oncology, The Chinese University of Hong Kong
Study Officials
- PRINCIPAL INVESTIGATOR
Winnie Yeo
Chinese University of Hong Kong-Prince of Wales Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2006
First Posted
May 4, 2006
Study Start
May 1, 2006
Primary Completion
August 1, 2010
Study Completion
October 1, 2012
Last Updated
November 6, 2017
Results First Posted
September 26, 2017
Record last verified: 2017-10