Status:
UNKNOWN
Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
KKS Netzwerk
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label, mono-center phase I/II study designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of RAD001 in combination with carboplatin in taxane- and a...
Detailed Description
During the phase I part the study will include at least 3 patients at each dose-level until MTD is reached. Each cohort will consist of newly enrolled patients. Intra-patient dose escalation is not pe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00930475
Start Date
February 1 2009
Last Update
January 26 2011
Active Locations (1)
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1
Charité, university medicine, Berlin, CCM
Berlin, State of Berlin, Germany, 10177