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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 March 2013 |
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Main ID: |
NCT00906698 |
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Date of registration:
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14/05/2009 |
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Primary sponsor: |
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Public title:
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Afatinib and Vinorelbine in Tumours Known to Overexpress EGFR and/or HER2
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Scientific title:
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Phase I Open Label Trial to Assess Safety of BIBW 2992 With Vinorelbine in Solid Tumors Known to Overexpress HER2 and/or EGFR |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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55 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00906698 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Boehringer Ingelheim |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boehringer Ingelheim Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Histologically or cytologically confirmed diagnosis of malignancy that is now
advanced, non resectable and/or metastatic
- Tumours historically known to overexpress EGFR and/or HER2
Exclusion criteria:
- Prior treatment with HER2 inhibiting drugs within the past 4 weeks before the start
of therapy or concomitantly with this trial.
- Prior treatment with EGFR inhibiting drugs within the past two weeks before the start
of therapy or concomitantly with this trial.
- Prior treatment with HER2 inhibiting drugs within the past two weeks before the start
of therapy or concomitantly with this trial.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neoplasms
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Intervention(s)
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Drug: BIBW 2992 20 mg/day
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Drug: BIBW 2992 40 mg/day
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Drug: BIBW 2992 50 mg/day
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Drug: BIBW 2992 high dosage
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Drug: BIBW 2992 low dosage
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Drug: BIBW 2992 medium dosage
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Drug: Vinorelbine i.v or per os
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Drug: Vinorelbine per os 60 mg/m²
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Drug: Vinorelbine per os 80 mg/m²
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Primary Outcome(s)
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To identify the MTD of BIBW 2992 therapy in combination with vinorelbine i.v. and vinorelbine oral.
[Time Frame: 28 days]
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Secondary Outcome(s)
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Incidence and intensity of AE according to NCI CTCAE classification v.3
[Time Frame: This endpoint has no specific timeframe]
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Overall response according to the RECIST criteria
[Time Frame: every 8 weeks]
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Pharmacokinetic characteristics of BIBW 2992, vinorelbine i.v. and vinorelbine oral
[Time Frame: 28 days]
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Secondary ID(s)
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1200.69
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2008-006290-32
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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