Clinical Trial Results:
Randomized Phase II Study of CABAZITAXEL versus METHOTREXATE in patients with recurrent or metastatic squamous cell carcinoma of the head and neck previously treated with platinum-based therapy
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Summary
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EudraCT number |
2011-001938-42 |
Trial protocol |
BE |
Global end of trial date |
03 Nov 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Mar 2021
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First version publication date |
10 Mar 2021
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Other versions |
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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 |
UCL-ONCO2011-01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01528163 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Cliniques universitaires Saint-Luc
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Sponsor organisation address |
Avenue Hippocrate, 10, Brussels, Belgium, 1200
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Public contact |
Centre du Cancer, Cliniques universitaires Saint-Luc, 0032 27645457, jean-pascal.machiels@uclouvain.be
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Scientific contact |
Centre du Cancer, Cliniques universitaires Saint-Luc, 0032 27645457, jean-pascal.machiels@uclouvain.be
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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 |
26 Jan 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
03 Nov 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Nov 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 |
Determine the efficacy of cabazitaxel in patients with head and neck cancer in terms of progression-free survival rate at 18 weeks (defined as the proportion of patients alive and free of progression at 18 weeks)
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Protection of trial subjects |
This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) régulations/guidelines, and country-specific national and local laws.
Safety was determined after each injection, after each assessment, after 3 cycles and every 9 weeks, depending on the course of the disease.
All observed or deliberate adverse events, regardless of the treatment group or suspected causal relationship with the investigational product, have been reported.
The investigator followed the outcome of any adverse event (clinical signs, laboratory or other values, etc) up to 28 days after the last administration. For adverse events causally related to the investigational product, investigator follow-up is necessary until the event or its sequelae are resolved or stabilized at a level acceptable to the investigator and the coordinator of the study.
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Background therapy |
Cabazitaxel: from 20 mg/m2 to 25 mg/m2. Intravenous injection every three weeks. | ||
Evidence for comparator |
Methotrexate: from 40 mg/m2 (first cycle) to 50 mg/m2. Intravenous injections every three weeks. | ||
Actual start date of recruitment |
24 Jan 2012
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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 |
Belgium: 99
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Country: Number of subjects enrolled |
Luxembourg: 2
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Worldwide total number of subjects |
101
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EEA total number of subjects |
101
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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) |
84
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From 65 to 84 years |
17
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85 years and over |
0
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Recruitment
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Recruitment details |
The subjects were recruited from 15 sites: 14 of which belong to the Member State (Belgium) and one site in Luxembourg. Participants were included from January 12, 2012 to July 11, 2014. | |||||||||
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Pre-assignment
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Screening details |
Patients with incurable squamous cell carcinoma of the head and neck with progression after platinum-based therapy were randomly assigned to cabazitaxel or methotrexate. All the patients provided written informed consent. | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Cabazitaxel | |||||||||
Arm description |
Patients receiving 20 mg/m2 to 25 mg/m2 Cabazitaxel intravenously every three weeks. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Cabazitaxel
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Investigational medicinal product code |
XRP6258
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Other name |
Jevtana
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Cabazitaxel was continued until progressive disease, unacceptable toxicity, or a maxima of 10 cycles.
The preparation of Cabazitaxel (XRP6258) infusion solution for administration requires the preparation of a premix solution at 60 mg/6 ml (nominal concentration). This must be done with a 13% m/m ethanol solution in water for injection (the "solvent") supplied with the cabazitaxel concentrate for solution for infusion ("preparation of the premix solution"). Then the premix solution must be diluted in an infusion vehicle ("preparation of the infusion solution") prior to administration.
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Arm title
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Methotrexate | |||||||||
Arm description |
From 40 mg/m2 (first cycle) to 50 mg/m2. Intravenous injections every three weeks. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Methotrexate
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Investigational medicinal product code |
SUB08856MIG
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Other name |
Emthexate
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Patients will start on a dose of 40 mg/m2 once weekly, and the dose increase to 50 mg/m2 will be based on the investigator’s clinical judgement.
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Baseline characteristics reporting groups
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Reporting group title |
Cabazitaxel
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Reporting group description |
Patients receiving 20 mg/m2 to 25 mg/m2 Cabazitaxel intravenously every three weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Methotrexate
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Reporting group description |
From 40 mg/m2 (first cycle) to 50 mg/m2. Intravenous injections every three weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Cabazitaxel
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Reporting group description |
Patients receiving 20 mg/m2 to 25 mg/m2 Cabazitaxel intravenously every three weeks. | ||
Reporting group title |
Methotrexate
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Reporting group description |
From 40 mg/m2 (first cycle) to 50 mg/m2. Intravenous injections every three weeks. | ||
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End point title |
Determine the efficacy of cabazitaxel in patients with head and neck cancer in terms of progression-free survival rate at 18 weeks [1] | ||||||||||||
End point description |
The primary endpoint was the progression-free survival rate (PFSR) at 18 weeks, defined as the proportion of patients alive and free of progression according to the RECIST at 18 weeks after treatment.
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End point type |
Primary
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End point timeframe |
18 weeks
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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: For the Primary Endpoint, descriptive statistics were performed and presented in proportion. The actual statistical analyzes were performed for the secondary endpoints. The Kaplan-Meier method was used to estimate the median PFS and OS times. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Progression-free survival | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
PFS was defined as the time interval between the date of randomization and the date of disease
progression or the date of death from any cause.
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Statistical analysis title |
the median PFS | ||||||||||||
Comparison groups |
Cabazitaxel v Methotrexate
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Number of subjects included in analysis |
101
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Analysis specification |
Pre-specified
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Analysis type |
other [2] | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
The Kaplan-Meier method | ||||||||||||
Confidence interval |
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95% | ||||||||||||
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End point title |
overall survival (OS) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
OS was defined as the time interval between the date of randomization until death from any cause or until the date of the last follow-up visit.
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Statistical analysis title |
Overall survival | ||||||||||||
Comparison groups |
Cabazitaxel v Methotrexate
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Number of subjects included in analysis |
101
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Analysis specification |
Pre-specified
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Analysis type |
other [3] | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
The Kaplan-Meier method | ||||||||||||
Confidence interval |
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| Notes [3] - Noncomparative |
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Adverse events information
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Timeframe for reporting adverse events |
All AEs observed regardless of treatment group or suspected cause-and-effect relationship with the investigational product were reported as soon as possible. Serious adverse events require immediate notification (within 24 hours).
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Adverse event reporting additional description |
The investigator should follow up the outcome of any Adverse Events (up to 28 days post last administration. For adverse events with a causal relationship to the investigational product, follow-up by the investigator is required until the event or its sequelae resolve or stabilize at a level acceptable to the investigator and the study coordinator.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
CTCAE GRADE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.03
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Reporting groups
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Reporting group title |
CABAZITAXEL
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Reporting group description |
Intravenous injection every three weeks from 20 mg/m2 to 25 mg/m2 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
METHOTREXATE
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Reporting group description |
Intravenous injections every three weeks from 40 mg / m2 (first cycle) to 50 mg / m2 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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07 Feb 2012 |
Amendment 1, version 1 |
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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 | |||
