Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
RAD001 (Everolimus) in combination with carboplatin
RAD001 (Everolimus) in combination with carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility 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
Sites / Locations
- Charité, university medicine, Berlin, CCMRecruiting
Outcomes
Primary Outcome Measures
Phase I: dose limiting toxicity
Phase II: response rate
Secondary Outcome Measures
Phase I: adverse events
Full Information
NCT ID
NCT00930475
First Posted
June 18, 2009
Last Updated
January 25, 2011
Sponsor
Charite University, Berlin, Germany
Collaborators
KKS Netzwerk, Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00930475
Brief Title
Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer
Official Title
Everolimus (RAD001) in Combination With Intravenous Carboplatin in Taxane- and Anthracycline-pretreated Patients With Progressive Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
KKS Netzwerk, Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
RAD001 (Everolimus) in combination with carboplatin
Intervention Description
phase I: dose levels: 2,5 mg, 5 mg, 7,5 mg and 10mg daily in combination with carboplatin AUC2 weekly until progress
Intervention Type
Drug
Intervention Name(s)
RAD001 (Everolimus) in combination with carboplatin
Intervention Description
phase 2: 10mg RAD001 in combination with carboplatin
Primary Outcome Measure Information:
Title
Phase I: dose limiting toxicity
Time Frame
after three weeks
Title
Phase II: response rate
Time Frame
every six weeks
Secondary Outcome Measure Information:
Title
Phase I: adverse events
Time Frame
after three weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Eucker, Dr. med.
Email
jan.eucker@charite.de
Facility Information:
Facility Name
Charité, university medicine, Berlin, CCM
City
Berlin
ZIP/Postal Code
10177
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Eucker, Dr. med.
12. IPD Sharing Statement
Learn more about this trial
Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer
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