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Phase I Trial of Afatinib and Trastuzumab in HER2 Overexpressing Cancer.

NCT01649271 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-02-11

Study results available
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Summary

The aim of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib in combination with 3-weekly trastuzumab in HER2 overexpressing cancer and to assess the efficacy of afatinib given at the MTD dosage, with 3-weekly trastuzumab in HER2 overexpressing metastatic breast cancer.

Conditions

  • Breast Neoplasms
  • Stomach Neoplasms

Interventions

DRUG

Herceptin

3-weekly

DRUG

afatinib

at MTD level

DRUG

trastuzumab

3-weekly

DRUG

Herceptin

weekly

DRUG

afatinib

at MTD level

DRUG

afatinib

escalating dose

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-23
Primary Completion
2016-06-23
Completion
2016-06-23

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
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 NCT01649271 on ClinicalTrials.gov