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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01649271
• Date of registration: 23/07/2012
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: Phase I Trial of Afatinib and Trastuzumab in HER2 Overexpressing Cancer.
• Scientific 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.
• Date of first enrolment: July 23, 2012
• Target sample size: 13
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01649271
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Breast Neoplasms

Stomach Neoplasms

Intervention(s)

Drug: Herceptin

Drug: trastuzumab

Drug: afatinib

Primary Outcome(s)

MTD of Afatinib in Combination With Trastuzumab Based on the Number of Patients With DLTs During the First Treatment Cycle (Afatinib). [Time Frame: First 21 days treatment cycle]

Dose Limiting Toxicities During cycle1 [Time Frame: First 21-day treatment cycle]

Secondary Outcome(s)

Clinical Benefit [Time Frame: Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 33 months]

Best Overall Response [Time Frame: Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until End of Treatment (EOT); up to 33 months]

Objective Response [Time Frame: Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 33 months]

Secondary ID(s)

2012-001753-10

1200.134

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/11/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01649271