Clinical Trial Results:
DANSAC-open: A multicenter, open label study to investigate the efficacy and tolerability of olanzapine in patients with advanced cancer not receiving chemotherapy or irradiation.
Summary
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EudraCT number |
2015-002294-38 |
Trial protocol |
DK |
Global end of trial date |
05 Sep 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Jan 2020
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First version publication date |
01 Jan 2020
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Other versions |
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Summary report(s) |
DANSAC_open, article |
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 |
DANSAC-open
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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 |
Odense University Hospital
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Sponsor organisation address |
JB Winsløws Vej 4, Odense, Denmark, 5000
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Public contact |
Signe Harder, Odense University Hospital, +45 4525382590, signe.harder@rsyd.dk
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Scientific contact |
Signe Harder, Odense University Hospital, +45 4525382590, signe.harder@rsyd.dk
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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 |
05 Sep 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
05 Sep 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Sep 2018
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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 |
Objectives: The primary objective is to test if olanzapine 10 mg is effective in patients with advanced cancer not receiving chemotherapy or irradiation.
Hypotheses: Administration of olanzapine will result in a change in nausea score from baseline to 24 hours later exceeding 30%. In patients included because of vomiting only (nausea score less than moderate), the primary parameter will be change in number of emetic episodes from baseline to 24 hours later.
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Protection of trial subjects |
Close follow-up, minimal procedures involved for the patient
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Mar 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Denmark: 40
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Worldwide total number of subjects |
40
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EEA total number of subjects |
40
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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) |
15
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From 65 to 84 years |
24
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85 years and over |
1
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Recruitment
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Recruitment details |
Slow recruitment | ||||||||||||||
Pre-assignment
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Screening details |
Patients both screened and directly referred for the trial (29 screened, 11 referred) | ||||||||||||||
Period 1
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Period 1 title |
Overall (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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All patients | ||||||||||||||
Arm description |
- | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
olanzapine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for solution for injection, Orodispersible tablet
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Routes of administration |
Oral use, Intravenous use
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Dosage and administration details |
First dose intravenous, following four doses as an orodispersable tablet
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Baseline characteristics reporting groups
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Reporting group title |
Overall
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
All patients
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Reporting group description |
- |
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End point title |
Effect [1] | ||||||
End point description |
Number of patients reporting a lower degree of nausea or a lower number of emetic episodes at 24 hous compared to baseline
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End point type |
Primary
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End point timeframe |
From baseline to 24 hours
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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: Reporting a single arm study, and even though the information button say I can choose just one arm, the validation of data keep making warnings despite many efforts to correct the error. |
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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 |
Adverse events evaluated 24 hours after first dose and at seven days
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Assessment type |
Systematic | ||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||||||||
Dictionary version |
4.0
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Reporting groups
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Reporting group title |
All patients
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Reporting group description |
- | ||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 2% | |||||||||||||||||||||||||||
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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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14 Nov 2016 |
1: change in time of medication from morning to bedtime
2: Removal of bloodsamples |
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01 Sep 2017 |
1: Change in exclusion criteria not allowing antineoplastic treatment from 4 weeks to 2 weeks
2: Expanding inclusion time to 36 months
3: Allowing dose reductions in case of adverse events |
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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 |