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Lapatinib and RAD-001 for HER2 Positive Metastatic Breast Cancer

NCT01283789 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-02-08

No results posted yet for this study

Summary

By doing this study, researchers hope to learn the effectiveness of the combination of Lapatinib and RAD-001 for treating patients who have progressed on previous therapies.

Conditions

Interventions

DRUG

Lapatinib and RAD-001

Lapatinib will be taken orally as a once-daily dose of 1250 mg (five 250 mg tablets) continuously from study day 1 until progression of disease. Patients will take the tablet at bedtime, at the same time each day, in a fasting state. Everolimus will be taken orally as a once-daily dose of 5 mg (one 5 mg tablet) from study day 1 until progression of disease. Patients will take the tablet at the same time each morning.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • GlaxoSmithKline

    collaborator INDUSTRY

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Qamar Khan, MD · University of Kansas Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2016-04-30
Completion
2017-04-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01283789 on ClinicalTrials.gov