Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B)

• Status: Active, not recruiting
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase II MATCH treatment trial identifies the effects of afatinib in patients whose cancer has genetic changes called HER2 mutations. Afatinib may stop the growth of cancer cells by blocking the HER2 receptor, a protein that may be needed for cell growth. Researchers hope to learn if afatinib will shrink this type of cancer or stop its growth.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Afatinib

Criteria

Inclusion Criteria:

• Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol

• Patient's tumor must have activating HER2 mutation, as determined via the MATCH Master Protocol

• Additionally, any in-frame insertions in exon 20 will be considered an activating mutation

• Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)

• Patients with known left ventricular dysfunction must have echocardiogram (ECHO) or a nuclear study (multiple-gated acquisition [MUGA] or First Pass) within 4 weeks prior to registration to treatment and must not have left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be > 50% for the patient to be eligible

• NOTE: Pre-treatment LVEF determination in patients without known left ventricular dysfunction is NOT otherwise required.

• Patients must have =< grade 1 diarrhea at baseline

• Patients must have =< grade 1 renal function as defined below:

• Creatinine =< 1.5 x normal institutional limits OR

• Measured creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal or as calculated by the Cockcroft-Gault equation

• This should be strictly followed and will override the MATCH Master Protocol requirements

Exclusion Criteria:

• Patients must not have known hypersensitivity to afatinib or compounds of similar chemical or biologic composition

• Patients with a history of interstitial lung disease will be excluded

• Patients must not have had prior treatment with any of the following tyrosine kinase inhibitors (TKIs), which have known activity against HER2 kinase:

• Neratinib

• AC-480 (BMS-599626)

• AST 1306

• Canertinib (CI 1033)

• CUDC-101

• Lapatinib

• TAK285

• Afatinib

• AEE 788

• AZD8931

• CP-724714

• Dacomitinib

• Pelitinib

• Patients with non-small cell lung cancer will be excluded