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| Sponsored by: |
All Ireland Cooperative Oncology Research Group |
| Information provided by: | All Ireland Cooperative Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT00566748 |
Purpose
This is a phase I study of fixed dose oral Lapatinib administered in combination with an increasing dose level of epirubicin in patients with metastatic breast cancer. This study is looking for the most tolerable combination of the treatments.
| Condition | Intervention | Phase |
|
Metastatic Breast Cancer |
Drug: Epirubicin and Lapatinib |
Phase I |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer |
| ChemIDplus related topics: | Lapatinib Lapatinib Ditosylate Epirubicin hydrochloride Epirubicin |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Open Label Phase I Study of Fixed Dose Lapatinib in Combination With an Escalating Dose of Epirubicin in Metastatic Breast Cancer |
| Estimated Enrollment: | 24 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | October 2008 |
| Arms | Assigned Interventions |
| I |
Drug: Epirubicin and Lapatinib
The efficacy of lapatinib in combination with epirubicin will be assessed by the objective response rate (ORR). The ORR will be assessed by CT scan every 2 cycles (6 weeks) or until disease progression, using the measurable disease criteria as defined by RECIST.
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This is an open-label Phase I study of fixed dose oral lapatinib administered in combination with an escalating dose of epirubicin in patients with metastatic breast cancer. This Phase I study employs a dose escalation scheme in order to determine the optimally-tolerated regimen (OTR) of lapatinib and epirubicin administered in combination. Secondary endpoints include assessment of the tumour response rate, pharmacokinetic analysis and evaluation of tumour biomarkers. Approximately fifteen to thirty (15-30) subjects are planned to be enrolled in this Phase I study. Following the completion of this Phase I study and the determination of the OTR of lapatinib and epirubicin a Phase II study will be initiated.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Female subjects must either be of:
Child-bearing potential (i.e. a woman with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility. This category includes women with oligomenorrhoea (even severe), women who are perimenopausal and young women who have begun to menstruate), who have a negative serum pregnancy test at screening, and agree to one of the following:
Consistent and correct use of one of the following acceptable methods of birth control:
Adequate haematology, renal and hepatic function
Exclusion Criteria:
Women will not be eligible for inclusion in this study if any of the following criteria apply:
Contacts and Locations| Contact: John Crown, Prof | +353-1-2094895 | john.crown@icorg.ie |
| Ireland, Dublin | |||||
| St. Vincent's Univeristy Hospital | Recruiting | ||||
| Elm Park, Dublin, Ireland, 4 | |||||
| Contact: Prof. John Crown +353-1-2094982 | |||||
| Principal Investigator: Prof. John Crown | |||||
| Adelaide and Meath National Children's Hopsital | Recruiting | ||||
| Tallaght, Dublin, Ireland, 24 | |||||
| Contact: Dr. Ray McDermott +353-1-4142892 | |||||
| Principal Investigator: Dr. Ray McDermott | |||||
| St. James's Hospital | Recruiting | ||||
| James's Street, Dublin, Ireland, 8 | |||||
| Contact: John Kennedy, MB FRCPI +353 1 4103754 | |||||
| Principal Investigator: John Kennedy, MB FRCPI | |||||
| Mater Hospitals | Recruiting | ||||
| Eccles Street, Dublin, Ireland, 7 | |||||
| Contact: John McCaffrey, MB MRCPI +353 1 803 4834 | |||||
| Principal Investigator: John McCaffrey, MB MRCPI | |||||
| All Ireland Cooperative Oncology Research Group |
| Study Chair: | John Crown, MB BCh BAO | St Vincent's University Hospital, Ireland |
More Information
| Responsible Party: | ICORG ( Oleh Martynyuck ) |
| Study ID Numbers: | ICORG 06-30 |
| First Received: | December 3, 2007 |
| Last Updated: | June 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00566748 |
| Health Authority: | Ireland: Irish Medicines Board |
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