Clinical Trial Results:
A pharmacokinetic study of capecitabine in patients undergoing peri-operative chemotherapy and a total gastrectomy for adenocarcinoma of the stomach.
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Summary
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EudraCT number |
2009-009908-39 |
Trial protocol |
GB |
Global end of trial date |
23 Oct 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Jul 2016
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First version publication date |
30 Jul 2015
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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 |
CAP002
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00871273 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Cambridge University Hospitals NHS Foundation Trust
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Sponsor organisation address |
Hills Road, Cambridge University Hospitals NHS Foundation Trus, United Kingdom, CB2 0QQ
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Public contact |
Chief Investigator, Cambridge University Hospitals NHS Foundation Trust
, 0044 1223216083, cctu.cancer@addenbrookes.nhs.uk
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Scientific contact |
Chief Investigator, Cambridge University Hospitals NHS Foundation Trust
, 0044 1223216083, cctu.cancer@addenbrookes.nhs.uk
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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 |
17 Oct 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Oct 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Oct 2013
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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 |
To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy
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Protection of trial subjects |
The study was approved by a Research Ethics Committee and received authorisation from the Medicines and Healthcare Products Regulatory Authority. Patients received verbal and written information prior to consenting to the trial and had the time to consider their participation and opportunity to ask questions. Consenting patients had a series of screening tests and exams to ensure they were suitable for the study and that it was safe to proceed. The patients were monitored in the clinic every 3 weeks during the pre-operative and post-operative cycles of treatment for assessment and monitoring of safety. On registration to the trial, the patients were allocated a unique reference number to be used on all data and samples sent to the Sponsor which allowed their personal data to remain anonymous. Only the patients' direct care team had access to their recruited participants personal data during the study. Patients were allowed to withdraw their consent to the study at any time. Patients were withdrawn from the study if they demonstrated disease progression or unacceptable toxicity.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
29 Jul 2010
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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 |
United Kingdom: 13
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Worldwide total number of subjects |
13
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EEA total number of subjects |
13
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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) |
3
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From 65 to 84 years |
10
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85 years and over |
0
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Recruitment
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Recruitment details |
The first patient was recruited on to the study on 29-Jul-2010. The last patient was recruited onto the study on 04-Mar-2013. Patients were recruited from Hospital Oncology clinics. | ||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Twenty-eight patients were approached for the trial. Of these, 15 did not enter the trial (8 patients declined to participate, 4 patients did not meet the meet the inclusion criteria and 3 patients were not suitable for other reasons). Thirteen patients were screened and were subsequently registered for the trial. | ||||||||||||||||||||||||
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Period 1
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Period 1 title |
On-Study (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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Capecitabine | ||||||||||||||||||||||||
Arm description |
All registered subjects, planned to receive capecitabine used as part of the ECX combination therapy | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Capecitabine
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Investigational medicinal product code |
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Other name |
Xeloda (trade name)
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
625 mg/m2, BID, for 21 days for 3 cycles pre-operatively and 3 cycles post-operatively
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Baseline characteristics reporting groups
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Reporting group title |
On-Study
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Full Analysis Set
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All subjects who entered the study for PK sampling
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End points reporting groups
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Reporting group title |
Capecitabine
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Reporting group description |
All registered subjects, planned to receive capecitabine used as part of the ECX combination therapy | ||
Subject analysis set title |
Full Analysis Set
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All subjects who entered the study for PK sampling
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End point title |
PK parameters for capecitabine AUC (0-infinity) [1] | ||||||||
End point description |
PK parameters for capecitabine AUC (0-infinity): ratio of AUC cycle 4/cycle 1
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End point type |
Primary
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End point timeframe |
cycle 1 to cycle 4
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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: This is a single arm PK study to investigate whether there is a difference in AUC of capecitabine between cycle 4 and cycle 1, measured by the ratio of cycle 4/cycle 1. A total of 5 patients completed both cycles. The mean and standard deviation of this ratio is 2.93 and 1.41, respectively. Using the one-sample t-test, the p-value of the null hypothesis that the ratio =1 is 0.0373. |
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Attachments |
CAP002 SAE listing |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From patient registration until 28 days after last study drug administration, regardless of the dose or causal relationship
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
NCI CTCAE | ||
Dictionary version |
3
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| 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: Serious adverse events are reported in the file found in the uploaded attachment. |
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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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10 Jul 2009 |
Substantial amendment in response to non-acceptance. Submission of trial-specific label.
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18 Sep 2009 |
Changes to the protocol V2.0 dated 18-Sep-2009 and patient information sheet V2.0 dated 18-Sep-2009 and informed consent form V2.0 dated 18-Sep-2009
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17 Mar 2010 |
Changes to the protocol V3.0 dated 17-Mar-2010, patient information sheet and informed consent form V3.0 dated 17-Mar-2010 and GP Letter V1.1 dated 17-Mar-2010
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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 | |||
