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Phase Ib/II Trials of RAD001 in Triple Negative Metastatic Breast Cancer

NCT01939418 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-10-03

No results posted yet for this study

Summary

This study consists of two parts. In a phase Ib part, investigators will explore the recommended dose of gemcitabine, cisplatin, and RAD001 combination in patients with metastatic TNBC. After completing the phase Ib part, investigators will review the data and discuss with Novartis before the start of a phase II part. In the phase II part, investigators will compare the efficacy of the gemcitabine and cisplatin with or without RAD001 in patients with metastatic TNBC.

Conditions

Interventions

DRUG

RAD001

Afinitor 5mg qd. po.

DRUG

Gemcitabine

gemcitabine 800mg/m2 iv. D1 and D8 every 3 weeks

DRUG

Cisplatin

cisplatin 30mg/m2 iv. D1 and D8 every 3 weeks

Sponsors & Collaborators

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • In Hae Park, Doctor · National Cancer Center, Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-07-30
Completion
2017-07-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01939418 on ClinicalTrials.gov