Clinical Trial Results:
A Multicenter, Open-Label Trial of Belinostat in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma
Summary
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EudraCT number |
2008-005843-40 |
Trial protocol |
DK FR IT NL BE DE ES HU SK PL GB |
Global end of trial date |
27 Oct 2014
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Results information
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Results version number |
v1 |
This version publication date |
11 Nov 2016
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First version publication date |
11 Nov 2016
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Other versions |
v2 |
Summary report(s) |
PDX-CLN19 Study Report PDX-CLN19 Investigator's Brochure version 13 Demographics Dispositions Adverse Events Serious Adverse Events Adverse Events By Preferred Term Related Treatment-Emergent Adverse Events By System Organ Class Serious Related Treatment-Emergent Adverse Events By System Organ Class |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PXD101-CLN-19
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00865969 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Spectrum Pharmaceuticals
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Sponsor organisation address |
157 Technology Drive, Irvine, United States, 92618
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Public contact |
Clinical Operations, Topotarget A/S, 45 39 17 83 92, enquiries@topotarget.com
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Scientific contact |
Clinical Operations, Topotarget A/S, 45 39 17 83 92, enquiries@topotarget.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
13 Dec 2013
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Oct 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to determine the objective response rate in patients with peripheral T cell lymphoma who are treated with belinostat monotherapy.
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Protection of trial subjects |
Informed Consent Form was used to ensure all participation is voluntary and study subjects are aware of their right, including personal health information privacy. Clinical monitoring visits were conducted throughout the life of study to ensure study patient safety are continuously monitored and protected. The assigned medical monitor also reviewed the data on frequent basis to ensure that all safety data are adequately monitored and issues addressed timely.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Dec 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 10
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Country: Number of subjects enrolled |
Israel: 4
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Country: Number of subjects enrolled |
Canada: 7
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Country: Number of subjects enrolled |
United States: 37
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Country: Number of subjects enrolled |
Croatia: 4
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Country: Number of subjects enrolled |
South Africa: 3
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Country: Number of subjects enrolled |
Poland: 8
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Country: Number of subjects enrolled |
Slovakia: 2
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Country: Number of subjects enrolled |
Spain: 2
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Country: Number of subjects enrolled |
United Kingdom: 3
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Country: Number of subjects enrolled |
Belgium: 11
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Country: Number of subjects enrolled |
Denmark: 4
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Country: Number of subjects enrolled |
France: 4
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Country: Number of subjects enrolled |
Germany: 16
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Country: Number of subjects enrolled |
Hungary: 11
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Country: Number of subjects enrolled |
Italy: 3
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Worldwide total number of subjects |
129
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EEA total number of subjects |
78
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
67
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From 65 to 84 years |
62
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
Pre-assignment
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Screening details |
Patients with relapsed or refractory T-Cell lymphoma must sign consent and meet all Inclusion/Exclusion criteria | ||||||
Period 1
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Period 1 title |
Baseline
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Belinostat | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Belinostat
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
1000 mg/m2 of Belinostat administered as a 30 minutes IV infusion on days 1-5 of every 3-week cycle
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Period 2
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Period 2 title |
Overall trial
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Is this the baseline period? |
No | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Belinostat | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Belinostat
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
1000 mg/m2 of Belinostat administered as a 30 minutes IV infusion on days 1-5 of every 3-week cycle
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End points reporting groups
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Reporting group title |
Belinostat
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Reporting group description |
- | ||
Reporting group title |
Belinostat
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Reporting group description |
- |
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End point title |
Objective Response Rate [1] | ||||||
End point description |
Overall study duration from first dose until 2 years after the first dose
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End point type |
Primary
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End point timeframe |
24 months
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The statistical analysis shows a 26% ORR of the total evaluable population of 120 subjects |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Patients must be carefully monitored for all adverse events that occur from the time Informed Consent is obtained until 30 days after the last study drug administration.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
13.0
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Frequency threshold for reporting non-serious adverse events: 0.05% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: 125 subjects out of 129 treated subjects had at least 1 non-serious adverse event. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |