Clinical Trial Results:
Safety of extended use of the weekly oral docetaxel formulation ModraDoc006/r in patients with advanced solid tumours
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Summary
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EudraCT number |
2017-000347-41 |
Trial protocol |
NL |
Global end of trial date |
16 Jul 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Nov 2022
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First version publication date |
06 Nov 2022
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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 |
N17DEX
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03150368 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Modra Pharmaceuticals
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Sponsor organisation address |
Barbara Strozzilaan 201, Amsterdam, Netherlands, 1083 HN
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Public contact |
M. Keessen, Modra Pharmaceuticals, 0031 0202050188, info@modrapharmaceuticals.com
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Scientific contact |
S. Marchetti, NKI-AVL, 0031 0205122446, s.marchetti@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 |
18 Dec 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
16 May 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Jul 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 |
To determine the safety of extended use treatment with weekly ModraDoc006/r available for patients who completed treatment in one of the phase I trials with ModraDoc006/r, who might have clinical benefit of continued treatment with the oral docetaxel formulation.
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Protection of trial subjects |
The study was conducted in accordance with the protocol, the current principles of the Declaration of Helsinki, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) requirements, the Medical Research Involving Human Subjects Act and any other applicable local laws and regulations.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 May 2017
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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: 17
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Worldwide total number of subjects |
17
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EEA total number of subjects |
17
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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) |
13
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From 65 to 84 years |
4
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85 years and over |
0
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Recruitment
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Recruitment details |
Written informed consent was obtained before the start of any study related procedures. Patients had the right to withdraw from the study at any time, without giving an explanation and without prejudice to their subsequent care. | ||||||
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Pre-assignment
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Screening details |
Screening assessments were done within 35 days before first dose according to the extended use program of ModraDoc006/r. In case of previous phase I studies with ModraDoc006/r with a duration of 4 weeks or less, the screening visit of this phase I study was used as screening visit for the present study (N17DEX). | ||||||
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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 |
Not applicable
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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ModraDoc006/r extension treatment | ||||||
Arm description |
ModraDoc006/r is administered in patients who participated in other phase I trials with ModraD0c006/r at a similar dose regimen as in the previous ModraDoc006/r study. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
ModraDoc006
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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 |
ModraDoc006 bi-daily once weekly (BIDW) 30 mg in the morning, and 20 mg in the evening
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Investigational medicinal product name |
ritonavir
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Investigational medicinal product code |
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Other name |
Norvir®
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
ritonavir bi-daily once weekly (BIDW) 100 mg in the morning, and 100 mg in the evening
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
ModraDoc006/r extension treatment
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Reporting group description |
ModraDoc006/r is administered in patients who participated in other phase I trials with ModraD0c006/r at a similar dose regimen as in the previous ModraDoc006/r study. | ||
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End point title |
Safety analysis [1] | ||||||||||||||||
End point description |
To determine the safety of extended use treatment with weekly ModraDoc006/r in patients who completed treatment in one of the phase I trials with ModraDoc006/r, who might derive clinical benefit by continued treatment with the oral docetaxel formulation
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End point type |
Primary
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End point timeframe |
Overall trial
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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 general, ModraDoc006/r was reasonably well tolerated. However, due to the low number of patients enrolled and the limited number of patients exposed for prolonged period of time to the study drug, no firm conclusions on the long-term safety of ModraDoc006/r should be drawn. |
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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 |
Toxicities were scored from the first study drug administration until the end of treatment visit.
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Adverse event reporting additional description |
Toxicity was scored according to the CTC-AE (Common Terminology Criteria for Adverse Events, version 3.0).
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
Full analysis set
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Reporting group description |
The full analysis set included all 17 enrolled patients. All patients received one or more doses of the study medication and are included in the per protocol analysis set and in the safety analysis set. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? 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 | |||
