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Lapatinib in Combination With Docetaxel in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer

NCT01044485 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2012-09-25

No results posted yet for this study

Summary

The objective of this phase I/ II study is therefore to assess the safety and efficacy of lapatinib in combination with docetaxel in patients with advanced cancer. Only patients in first line treatment for metastatic disease should be included in the present study. It is proposed to start with a phase I part evaluating the safety of lapatinib 1250 mg with docetaxel 75 mg/m² without systematic support of growth factors, starting after the completion and data from the 1000 mg lapatinib +75 mg/m² docetaxel dose level in the EORTC (Bonnefoi) study.The objective of the phase II part will confirm the safety and evaluate efficacy of lapatinib in combination with docetaxel.

Conditions

Interventions

DRUG

lapatinib

escalation dose from 1250 to 1500 mg in association with docetaxel

DRUG

docetaxel

escalation dose from 75 mg/m2 to 100 mg/m2 in association with lapatinib

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Sanofi

    collaborator INDUSTRY

  • Centre Georges Francois Leclerc

    lead OTHER

Principal Investigators

  • Nicolas Isambert, MD · Centre Georges François Leclerc

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
2008-11-30
Primary Completion
2011-11-30

Countries

  • France

Study Locations

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Entities

Drugs
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 NCT01044485 on ClinicalTrials.gov