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Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer

NCT00930475 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2011-01-26

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • KKS Netzwerk

    collaborator NETWORK

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • Charite University, Berlin, Germany

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00930475 on ClinicalTrials.gov