Clinical Trial Results:
The efficacy of cabozantinib in advanced salivary gland cancer patients, a phase II clinical trial
Summary
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EudraCT number |
2018-000682-36 |
Trial protocol |
NL |
Global end of trial date |
06 Nov 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Jun 2022
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First version publication date |
24 Jun 2022
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Other versions |
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 |
NL65109.091.18
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Radboud university medical center
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Sponsor organisation address |
Geert Grooteplein Zuid 10, Nijmegen, Netherlands,
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Public contact |
Hettie Maters, Radboud university medical center, hettie.maters@radboudumc.nl
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Scientific contact |
Hettie Maters, Radboud university medical center, hettie.maters@radboudumc.nl
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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 |
06 Nov 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
06 Nov 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Nov 2019
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
Assess the overall response rate (ORR) of cabozantinib in advanced salivary gland cancer patients. ORR is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient.
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Protection of trial subjects |
In order to minimize risk of this experimental treatment, we took certain measures. First of all, only patients with a reasonable health (see inclusion criteria) can be included. Second,
we use the Simon 2-stage design in order to minimize exposure of patients in case of minimal efficacy. Third, we took standard precautions such as moderate monitoring according to NFU guidelines. And Finally, we will only include c-MET positive tumors in order to increase the chance of treatment efficacy.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Sep 2018
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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: 25
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Worldwide total number of subjects |
25
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EEA total number of subjects |
25
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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) |
18
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From 65 to 84 years |
7
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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 |
general inclusion criteria - Age ≥18 years - Eastern Cooperative Oncology Group performance status of 0 or 1. - adequate organ function | ||||||
Period 1
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Period 1 title |
Trial (overall period)
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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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single arm | ||||||
Arm description |
single arm | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
cabozantinib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
60 mg once daily
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End points reporting groups
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Reporting group title |
single arm
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Reporting group description |
single arm |
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End point title |
objective response rate [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
the best response from start of the trial until termination
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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: in this single arm study no statistical analysis could be performed. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
whole trial
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Adverse event reporting additional description |
CTCAE version 5
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
5
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Reporting groups
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Reporting group title |
trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |