Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end of trial. The end of trial is one year after the last patient has entered the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
afatinib starting at 30 mg daily dose
Mayo Clinic-Arizona
Scottsdale, Arizona, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States
City of Hope
Duarte, California, United States
Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction of Afatinib
On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).
Time frame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Percentage of Participants With Adverse Event = Diarrhoea of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Higher
Percentage of participants with adverse event being diarrhoea of CTCAE grade 3 or higher. On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).
Time frame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Percentage of Participants With Adverse Event = Rash/Acne (Grouped Term) of CTCAE Grade 3 or Higher
Percentage of participants with adverse event = rash/acne (grouped term) of CTCAE grade 3 or higher. MedDRA preferred terms that described AEs of similar nature were grouped together as "grouped term" to ensure that important events would not be underestimated. On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).
Time frame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, United States
University of Miami
Miami, Florida, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Baystate Health D'Amour Center for Cancer Care
Springfield, Massachusetts, United States
Montefiore Medical Center
The Bronx, New York, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Percentage of Participants With Adverse Event = Stomatitis (Grouped Term) of CTCAE Grade 3 or Higher
Percentage of participants with adverse event = stomatitis (grouped term) of CTCAE grade 3 or higher. MedDRA preferred terms that described AEs of similar nature were grouped together as "grouped term" to ensure that important events would not be underestimated. On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).
Time frame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Percentage of Participants With Adverse Event = Paronychia (Grouped Term) of CTCAE Grade 3 or Higher
Percentage of participants with adverse event = paronychia (grouped term) of CTCAE grade 3 or higher. MedDRA preferred terms that described AEs of similar nature were grouped together as "grouped term" to ensure that important events would not be underestimated. On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).
Time frame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Time to First Dose Reduction of Afatinib Caused by Adverse Events
Time to first dose reduction of afatinib caused by adverse events is defined as time from the date of the first administration of afatinib to the date of first dose reduction of afatinib caused by adverse events. Participants without AEs leading to dose reduction were censored at date of last intake of afatinib. On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent from study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria). The cumulative probability of no dose reduction at the respective time point is given by the Kaplan-Meier estimate at the respective time point based on time to first dose reduction of afatinib caused by adverse events.
Time frame: On-treatment period, up to 1057 days