NCT01649271

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

Phase I Trial of Afatinib in Combination With 3 Weekly Trastuzumab in Patients With Tumours Overexpressing HER2. Once the MTD of Afatinib With 3 Weekly Trastuzumab Was Established the Safety of This Dose Will be Assessed Also in Combination With Weekly Trastuzumab.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2012-07-23
• Primary completion: 2016-06-23
• Completion: 2016-06-23
• First posted: 2012-07-25
• Last updated: 2025-02-11
• Results posted: 2017-11-06

Locations

3 sites across 1 country: France