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

This study is currently recruiting participants.
Verified April 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01649271
First received: July 23, 2012
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Stomach Neoplasms
Drug: Herceptin
Drug: afatinib
Drug: trastuzumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Phase Ib: Objective response according to RECIST criteria version 1.1. [ Time Frame: up to 40 months ] [ Designated as safety issue: No ]
  • Phase Ia: Determination of Maximum Tolerated Dose (MTD) of afatinib in combination with 3 weekly trastuzumab based on the occurence of DLTs during first treatment course. [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase Ib: Progression Free Survival (PFS). Phase Ib: Best Overall Response (Complete Response, Partial Response or stable disease). [ Time Frame: up to 40 months ] [ Designated as safety issue: No ]
  • Phase Ib: Clinical benefit: Objective Response and Stable disease according to RECIST criteria version 1.1. [ Time Frame: up to 40 months. ] [ Designated as safety issue: No ]
  • Phase Ia: Objective response according to the RECIST criteria version 1.1. [ Time Frame: up to 40 months. ] [ Designated as safety issue: No ]
  • Phase Ia: Best overall response according to the Recist criteria version 1.1. [ Time Frame: up to 40 months. ] [ Designated as safety issue: No ]
  • Phase Ib: Best Overall Response (Complete Response, Partial Response or stable disease) [ Time Frame: up to 40 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase Ia, group 1
afatinib escalating dose with 3-weekly trastuzumab
Drug: Herceptin
3-weekly
Drug: afatinib
escalating dose
Experimental: Phase Ia, group 2
afatinib at MTD dose with weekly trastuzumab
Drug: afatinib
at MTD level
Drug: Herceptin
weekly
Experimental: Phase Ib
afatinib at MTD level with 3-weekly trastuzumab
Drug: trastuzumab
3-weekly
Drug: afatinib
at MTD level

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Patients aged 18 years and older
  2. Patients with cancers overexpressing HER2 by Immunohistochemistry test( IHC) 3+ and/or IHC 2+ with positive gene amplification by FISH (confirmation on archived tissue needed)
  3. Written informed consent that is consistent with ICH-GCP guidelines.
  4. Patients must be eligible for treatment with trastuzumab.
  5. Patients must have adequate organ function (kidney, liver, bone marrow, cardiac)
  6. Eastern Cooperative Oncology Group (ECOG) = 0 or 1.
  7. Measurable disease according to RECIST 1.1 (Phase Ib).

Exclusion criteria:

  1. Active brain metastases.
  2. Prior treatment with erbB family targeting therapies within the past four weeks before start of therapy or concomitantly with the trial other than trastuzumab and/or lapatinib.
  3. Patients having more than 2 lines of chemotherapy for the treatment of metastatic breast cancer (Phase Ib).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649271

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
France
1200.134.33002 Boehringer Ingelheim Investigational Site Recruiting
Dijon Cedex, France
1200.134.33003 Boehringer Ingelheim Investigational Site Recruiting
Saint Herblain Cedex, France
1200.134.33001 Boehringer Ingelheim Investigational Site Recruiting
Toulouse cedex, France
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01649271     History of Changes
Other Study ID Numbers: 1200.134, 2012-001753-10
Study First Received: July 23, 2012
Last Updated: April 2, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Stomach Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014