Clinical Trial Results:
A Phase II study of lapatanib and capecitabine in the treatment of metastatic pancreatic cancer
|
Summary
|
|
EudraCT number |
2008-006907-22 |
Trial protocol |
IE |
Global end of trial date |
11 Aug 2010
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
24 Feb 2025
|
First version publication date |
04 Feb 2021
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
08-39
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT00962312 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Cancer Trials Ireland
|
||
Sponsor organisation address |
Innovation House, Old Finglas Road, Dublin 11, Ireland, D11 KXN4
|
||
Public contact |
Anna Shevlin, Cancer Trials Ireland, +353 16677211, info@cancertrials.ie
|
||
Scientific contact |
Anna Shevlin, Cancer Trials Ireland, +353 16677211, info@cancertrials.ie
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
22 Nov 2012
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
11 Aug 2010
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
11 Aug 2010
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
To evaluate the efficacy of Capecitabine in combination with Lapatinib, in terms of overall survival, in the first line treatment of patients with metastatic Pancreatic cancer.
|
||
Protection of trial subjects |
This clinical study was designed, implemented, and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations SI 190 of 2004 as amend and European Directive 2001/20/EC. The study was approved by the HPRA and SJH/AMNCH Research Ethics Committee.
|
||
Background therapy |
N/A | ||
Evidence for comparator |
N/A | ||
Actual start date of recruitment |
07 Jul 2009
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Ireland: 9
|
||
Worldwide total number of subjects |
9
|
||
EEA total number of subjects |
9
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
5
|
||
From 65 to 84 years |
4
|
||
85 years and over |
0
|
||
|
|||||||
|
Recruitment
|
|||||||
Recruitment details |
The first patient was enrolled in May 2009. 9 patients were recruited in total. The last patient was recruited in April 2010. | ||||||
|
Pre-assignment
|
|||||||
Screening details |
The target population will be chemotherapy naïve patients with a histologically or cytologically confirmed adenocarcinoma of the pancreas with evidence of metastatic disease | ||||||
|
Period 1
|
|||||||
Period 1 title |
Overall Trial (overall period)
|
||||||
Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
|
||||||
Blinding used |
Not blinded | ||||||
|
Arms
|
|||||||
|
Arm title
|
Overall Trial | ||||||
Arm description |
Chemotherapy naïve patients with a histologically or cytologically confirmed adenocarcinoma of the pancreas with evidence of metastatic disease who fulfill all the Inclusion Criteria and none of the Exclusion Criteria | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Lapatinib
|
||||||
Investigational medicinal product code |
GW572016
|
||||||
Other name |
Tykerb,Tyverb
|
||||||
Pharmaceutical forms |
Tablet
|
||||||
Routes of administration |
Oral use
|
||||||
Dosage and administration details |
Patients receive 1250mg/day lapatinib orally continuously for 21 days
|
||||||
Investigational medicinal product name |
Capecitabine
|
||||||
Investigational medicinal product code |
|||||||
Other name |
Xeloda
|
||||||
Pharmaceutical forms |
Tablet
|
||||||
Routes of administration |
Oral use
|
||||||
Dosage and administration details |
Patients will receive 1000mg/m2 capecitabine TWICE daily (morning and evening doses) orally on days 1-14 of the 21 day cycle
|
||||||
|
|||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall Trial
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Overall Trial
|
||
Reporting group description |
Chemotherapy naïve patients with a histologically or cytologically confirmed adenocarcinoma of the pancreas with evidence of metastatic disease who fulfill all the Inclusion Criteria and none of the Exclusion Criteria | ||
|
|||||||||
End point title |
Overall Survival (OS) [1] | ||||||||
End point description |
The study used the six-month survival as the Primary Endpoint. Patients who were still living six months after the last patient has been enrolled were to be censored for the analyses, using the number of days between enrolment and the date of their last follow-up as their overall survival measurement.
The first stage of the study was to recruit 12 patients and if at least 7 met the survival criteria, a further 20 patients were to be enrolled. 9 patients were recruited to the first stage and 7 of them did not meet the overall survival criteria. Recruitment to the first stage was stopped to further accrual as the study primary outcome survival measure could no longer be met. Survival Analysis was therefore not carried out due to small numbers.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Overall survival will be defined as the interval between the date of first dose of study drug and the date of death.
|
||||||||
| 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: Patients who were still living six months after the last patient has been enrolled were to be censored for the analyses, using the number of days between enrolment and the date of last follow-up. 7 out of the 9 patients recruited to the first stage did not meet this survival criteria. Recruitment to the first stage was stopped to further accrual as the study primary outcome survival measure could no longer be met. Survival Analysis was therefore not carried out due to small numbers. |
|||||||||
|
|||||||||
| Notes [2] - Survival Analysis not carried out due to small numbers |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Progression Free Survival | ||||||||
End point description |
Patients who were still living six months after the last patient has been enrolled were to be censored for the analyses, using the number of days between enrolment and the date of last follow-up.
9 patients were recruited to the first stage and 7 of them did not meet the survival criteria. Recruitment to the first stage was stopped to further accrual as the study primary outcome survival measure could no longer be met. Survival Analysis was therefore not carried out due to small numbers.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Measured in months (or fraction of months) from drug administration to disease progression
|
||||||||
|
|||||||||
| Notes [3] - Analysis not carried out due to small number of patients |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
May 2009 - May 2010 (one year)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Study Population
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Patients with a histologically or cytologically confirmed adenocarcinoma of the pancreas with evidence of metastatic disease | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
28 Nov 2008 |
Amendment to Protocol - Updated to Version 2.0, 12Nov2008.
Protocol cover page administrative changes:
- protocol authors section deleted from cover page of protocol
- Chief Investigator Dr Ray McDermott is noted instead now as "Chief Investigator (clinical)"
- Dr Robert O'Connor, NICB Dublin City University is noted instead now as "Chief Investigator (translational)".
- Addition of Sub Investigator: Dr Rizwan Sheikh at AMNCH Hospital.
- Administrative change to Protocol: Summary of Time and Events table (Appendix C) - footnotes had not matched up correctly in previous protocol version - now corrected.
|
||
09 Oct 2009 |
Protocol updated to V3.0 20Aug 2009. Below are details of the updates:
-Revised protocol template format (following an update to internal ICORG SOPs).
Additional protocol text clarifications per study Chief Investigator:
- Clarification that total dosage of 2000mg/m2/day is administered as 2 doses of 1000mg/m2 (morning and evening doses).
- Table included as Appendix from Xeloda SPC for calculating standard and reduced doses of Capecitabine according to BSA for starting dose of 1000mg/m2.
- Clarification that GSK are no longer prohibiting certain gastic pH modifiers (H2 blockers and PPIs).
- Lapatinib specific rash management guidelines attached as Appendix.
- Sub-study serum specimen procurement processing and storage details attached as Appendix.
- Clarification revision of inclusion criterion no. 1: "patients must have histological or cytologically confirmed adenocarcinoma of the pancreas with evidence of metastatic disease." [previous noted as: patients must have histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas].
- Clarification revisions to Time and Events Table: removal of 6-weekly procedures column from Table and related text - not required as all procedures are listed in 3-weekly procedures column and text.
|
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| If seven or more patients to be recruited in the first stage had a six month survival, a further 20 patients were planned to be recruited to the second stage. The specified study survival criterion was not met and the study was stopped prematurely. | |||
