NCT04439136Active, not recruitingPhase 2
Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B)
MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients With Tumors With HER2 Activating Mutations
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 18 Jun 2020
- Start date
- 12 Aug 2015
- Primary completion date
- 22 Jan 2021
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Multiple myeloma
- NCT number
- NCT04439136
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 40
- From 12 Aug 2015 to the primary completion date, 22 Jan 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 with non-small cell lung cancer will be excluded
Lab values
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.