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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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17 October 2012 |
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Main ID: |
NCT00930475 |
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Date of registration:
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18/06/2009 |
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Primary sponsor: |
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Public title:
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Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer
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Scientific title:
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Everolimus (RAD001) in Combination With Intravenous Carboplatin in Taxane- and Anthracycline-pretreated Patients With Progressive Metastatic Breast Cancer |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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54 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00930475 |
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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/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Jan Eucker, Dr. med. |
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Address:
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Telephone:
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Email:
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jan.eucker@charite.de |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adult female patients
- at least two prior chemotherapies due to metastatic or inoperable breast cancer
- Karnofsky performance status of at least 60%
- pretreatment with at least one taxane and one anthracycline
Exclusion Criteria:
- previous treatment with mTOR-inhibitors, carboplatin, cisplatin or oxaliplatin
- inadequate organ function including bone marrow function
- bleeding tumours
- known uncontrolled metastases in CNS or carcinomatous meningosis
- patients who have been treated during the last five days with inhibitors or inducers
of CYP3A
- serious pulmonary, neurological, endocrinological or other disorders interfering with
this study medication, especially patients with known lung fibrosis, emphysema or
severe COPD
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: RAD001 (Everolimus) in combination with carboplatin
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Primary Outcome(s)
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Phase I: dose limiting toxicity
[Time Frame: after three weeks]
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Phase II: response rate
[Time Frame: every six weeks]
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Secondary Outcome(s)
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Phase I: adverse events
[Time Frame: after three weeks]
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Secondary ID(s)
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CRAD001JDE15T
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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