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Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: RAD001 (Everolimus) in combination with carboplatin
Type: Drug
Name: RAD001 (Everolimus) in combination with carboplatin
Type: Drug
Overall Status
Recruiting
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 anthracycline-pretreated patients with progressive metastatic breast cancer. Additionally, the study is designed to characterize the safety, the tolerability and efficacy of this study.
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 permitted. Once MTD is reached a total of 6 patients will be treated at MTD (phase I). For the phase II the minimax two-stage design will be applied. After testing the drug on 16 patients in the first stage of phase II, the trial will be terminated if 1 or fewer respond (SD, PR, CR). If the trial goes on to the second stage, a total of 34 patients will be studied during the phase II part.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
- 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
Location
Charité, university medicine, Berlin, CCM
Berlin, Germany
Status: Recruiting
Start Date
February 2009
Sponsors
Charite University, Berlin, Germany
Source
Charite University, Berlin, Germany
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page