Clinical Trial Results:
Selecting cancer patients for treatment using Tumor Organoids, the SENSOR study
Summary
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EudraCT number |
2014-003811-13 |
Trial protocol |
NL |
Global end of trial date |
16 Apr 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
20 Jun 2021
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First version publication date |
20 Jun 2021
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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 |
N14SNS
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
ABR : NL50400.031.14 | ||
Sponsors
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Sponsor organisation name |
Antoni van Leeuwenhoek - Netherlands Cancer Institute
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Sponsor organisation address |
Plesmanlaan 121, Amsterdam, Netherlands,
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Public contact |
Emile Voest, Antoni van Leeuwenhoek - Netherlands Cancer Institute, +31 205129111, e.voest@nki.nl
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Scientific contact |
Emile Voest, Antoni van Leeuwenhoek - Netherlands Cancer Institute, +31 205129111, e.voest@nki.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 |
16 Apr 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
16 Apr 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Apr 2019
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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 |
Evaluate the efficacy of patient-derived tumor organoids to successfully allocate patients for treatment with specific targeted agents.
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Protection of trial subjects |
Histological biopsies were obtained with the same high quality standards as biopsy procedures in regular care.
Upon experimental treatment, patients were tightly monitored within a designated clinical research department (Clinical Research Unit).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 2016
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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: 61
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Worldwide total number of subjects |
61
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EEA total number of subjects |
61
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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) |
44
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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 |
Metastatic colorectal cancer (CRC) patients without curative treatment options were accrued at The Netherlands Cancer Institute before start of their last SOC treatment | |||||||||||||||
Pre-assignment
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Screening details |
- | |||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
61 | |||||||||||||||
Number of subjects completed |
6 | |||||||||||||||
Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
No biopsy: 7 | |||||||||||||||
Reason: Number of subjects |
Unsuccessful organoid culture: 23 | |||||||||||||||
Reason: Number of subjects |
No drug screen performed: 6 | |||||||||||||||
Reason: Number of subjects |
No hit in drug screen: 6 | |||||||||||||||
Reason: Number of subjects |
No treatment started: 13 | |||||||||||||||
Period 1
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Period 1 title |
Treatment (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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Are arms mutually exclusive |
Yes
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Arm title
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Capivasertib | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Capivasertib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Orodispersible tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Twice daily, 125 mg in 28-day cycles using an intermittent dosing schedule (2 days on/5 days off)
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Arm title
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Vistusertib | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Vistusertib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Orodispersible tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Twice daily, at a dose of 480 mg in 28-day cycles using an intermittent dosing schedule (4 days on/3 days off)
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: There was a high drop-out of patients before initiating treatment within the trial. This is explained in the pre-assignement period |
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Baseline characteristics reporting groups
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Reporting group title |
Treatment
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Capivasertib
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Reporting group description |
- | ||
Reporting group title |
Vistusertib
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Reporting group description |
- |
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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 |
Response evaluation
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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: Please see final manuscript at PMID:33887686 |
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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 |
Anytime during treatment
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||
Dictionary version |
5.0
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Frequency threshold for reporting non-serious adverse events: 5% | |||
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: Please see final manuscript at PMID:33887686 |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/33887686 |