Clinical Trial Results:
Reintroduction of platinum-based therapy after treatment with trabectedin in patients with relapsed ovarian cancer resistant to platinum
Summary
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EudraCT number |
2014-004020-21 |
Trial protocol |
ES |
Global end of trial date |
16 Jan 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Apr 2021
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First version publication date |
24 Apr 2021
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Other versions |
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Summary report(s) |
Resumen en español |
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 |
PR-Trab-PT
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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 |
Fundación Investigación Biomédica Hospital Clínico San Carlos
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Sponsor organisation address |
Profesor Martin Lagos s/n , Madrid, Spain, 28040
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Public contact |
ana belen rivas paterna, UICEC, 0034 913303000ext7360, fibucicec.hcsc@saldud.madrid.org
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Scientific contact |
ana belen rivas paterna, UICEC, 91330373 913303000ext7360, fibucicec.hcsc@saldud.madrid.org
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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 |
13 Dec 2019
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Jan 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 |
Objective response rate and time to pathology progression (assessed according to RECIST 1.1)
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Protection of trial subjects |
Follow up for 4 months after the treatment finished
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jan 2015
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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 |
Spain: 10
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Worldwide total number of subjects |
10
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EEA total number of subjects |
10
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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) |
5
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From 65 to 84 years |
5
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment started on June 2015 and finished on December 2017 | ||||||
Pre-assignment
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Screening details |
- | ||||||
Pre-assignment period milestones
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Number of subjects started |
10 | ||||||
Number of subjects completed |
10 | ||||||
Period 1
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Period 1 title |
treatment period (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Trabectidine | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Yondelis
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
1,3 mg/m2
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Baseline characteristics reporting groups
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Reporting group title |
Trabectidine
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Trabectidine
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Reporting group description |
- |
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End point title |
The primary end points of the study were to compare time to first progression with platinum pre-trabectedin (TTP1) with time to second progression with platinum post-trabectedin (TTP2) [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
time to second progression with platinum post-trabectedin
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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 evaluation criterion, the objective response rate (TR) It was carried out by a Bayesian analysis. The Bayes quadratic loss estimator with its confidence interval (CI, credible region) also was analysed. Only one arm. |
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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 |
From the signing of the informed consent until 30 days after the suspension of the investigational product.
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Assessment type |
Systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||
Dictionary version |
4.3
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Reporting groups
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Reporting group title |
Asthenia
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Reporting group description |
Only one patient shown asthenia during the treatment | ||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 4% | |||||||||||||||
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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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30 Sep 2016 |
Changes in inclusion ans exclusion criterias |
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27 Jan 2017 |
Protocol: Changes in inclusion and dose criterias.
ICF: Patient Information Updated |
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16 Jan 2018 |
Investigator´s brochure update |
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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 |