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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-23

Study Completion Date

2016-06-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Neoplasms Stomach Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase Ia, group 1

afatinib escalating dose with 3-weekly trastuzumab

Group Type EXPERIMENTAL

Herceptin

Intervention Type DRUG

3-weekly

afatinib

Intervention Type DRUG

escalating dose

Phase Ia, group 2

afatinib at MTD dose with weekly trastuzumab

Group Type EXPERIMENTAL

afatinib

Intervention Type DRUG

at MTD level

Herceptin

Intervention Type DRUG

weekly

Phase Ib

afatinib at MTD level with 3-weekly trastuzumab

Group Type EXPERIMENTAL

trastuzumab

Intervention Type DRUG

3-weekly

afatinib

Intervention Type DRUG

at MTD level

Interventions

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Herceptin

3-weekly

Intervention Type DRUG

afatinib

at MTD level

Intervention Type DRUG

trastuzumab

3-weekly

Intervention Type DRUG

Herceptin

weekly

Intervention Type DRUG

afatinib

at MTD level

Intervention Type DRUG

afatinib

escalating dose

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No