NCT00930475

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2009

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

January 26, 2011

Status Verified

June 1, 2010

Enrollment Period

1.8 years

First QC Date

June 18, 2009

Last Update Submit

January 25, 2011

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Phase I: dose limiting toxicity

    after three weeks

  • Phase II: response rate

    every six weeks

Secondary Outcomes (1)

  • Phase I: adverse events

    after three weeks

Interventions

RAD001 (Everolimus) in combination with carboplatinDRUG

phase I: dose levels: 2,5 mg, 5 mg, 7,5 mg and 10mg daily in combination with carboplatin AUC2 weekly until progress

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité, university medicine, Berlin, CCM

Berlin, State of Berlin, 10177, Germany

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

EverolimusCarboplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsCoordination Complexes

Central Study Contacts

Jan Eucker, Dr. med.

CONTACT

jan.eucker@charite.de

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 18, 2009

First Posted

June 30, 2009

Study Start

February 1, 2009

Primary Completion

December 1, 2010

Last Updated

January 26, 2011

Record last verified: 2010-06

Locations

DE(1)