Status:
ACTIVE_NOT_RECRUITING
Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B)
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma. SECONDAR...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 12 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04439136
Start Date
August 12 2015
End Date
March 17 2026
Last Update
September 5 2025
Active Locations (1)
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1
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, United States, 19103