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Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00930475
Recruitment Status : Unknown
Verified June 2010 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : June 30, 2009
Last Update Posted : January 26, 2011
Sponsor:
Collaborators:
KKS Netzwerk
Novartis Pharmaceuticals
Information provided by:
Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE June 18, 2009
First Posted Date  ICMJE June 30, 2009
Last Update Posted Date January 26, 2011
Study Start Date  ICMJE February 2009
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
  • Phase I: dose limiting toxicity [ Time Frame: after three weeks ]
  • Phase II: response rate [ Time Frame: every six weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00930475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
Phase I: adverse events [ Time Frame: after three weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer
Official Title  ICMJE Everolimus (RAD001) in Combination With Intravenous Carboplatin in Taxane- and Anthracycline-pretreated Patients With Progressive Metastatic Breast Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: RAD001 (Everolimus) in combination with carboplatin
    phase I: dose levels: 2,5 mg, 5 mg, 7,5 mg and 10mg daily in combination with carboplatin AUC2 weekly until progress
  • Drug: RAD001 (Everolimus) in combination with carboplatin
    phase 2: 10mg RAD001 in combination with carboplatin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 29, 2009)
54
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00930475
Other Study ID Numbers  ICMJE CRAD001JDE15T
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Jan Eucker, Charite University medicine, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE
  • KKS Netzwerk
  • Novartis Pharmaceuticals
Investigators  ICMJE Not Provided
PRS Account Charite University, Berlin, Germany
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP