A phase II study to evaluate prophylactic treatment of dacomitinib-induced dermatologic adverse events in EGFR-mutated advanced non-small cell lung cancer - SPIRAL-Daco study

Takayama Koichi0 sites41 target enrollmentJuly 8, 2019

Conditionsnon-small cell lung cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: non-small cell lung cancer
Sponsor: Takayama Koichi
Enrollment: 41
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This prospective trial aimed to evaluate the effect of prophylactic intervention for skin toxicities, due to dacomitinib treatment. We enrolled 41 patients. As for Primary endpoint,18 patients(43.9%) had skin toxicities(>= grade2) in initial 8 weeks. The Upper limit of 90%CI was over pre-planned threshold. Skin toxicities caused dose reduction of dacomitinib treatment in 8 patients(19.5%). Grade3 or more adverse events was 17 patients (41.5%). The most common adverse event was anorexia in 6 patients(14.6%).

Registry

who.int

Start Date

July 8, 2019

End Date

April 30, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Takayama Koichi

Eligibility Criteria

Inclusion Criteria

•1\.Patients are \>\=20 years old (at the time of providing informed consent)
•2\. Patients with histolog ically or cytolog ically
•confirmed non\-small cell lung cancer
•3\. Patients with EGFR mutation positive
•4\. Patients at a stag e of IIIB/IIIC or IV who are inoperable or who experienced postoperative recurrence
•5\. No treatment history of dacomitinib
•6\. Patients with at least 1 measurable lesion
•according to RECIST v1\.1 criteria
•7\. Patients with performance status (ECOG) of 0\-2
•8\. Patients for whom bone marrow, hepatic, and renal functions have all been confirmed as normal within 2 weeks prior to enrollment according to the following clinical test

Exclusion Criteria

•1\. Patients with active double cancer (synchronous double cancer and metachronous double cancer within 5 years of disease\-free interval. However, the lesions correspondent to carcinoma in situ and intramucosal carcinoma curable by topical treatment are excluded)
•2\. Patients without intention of preventing contraception or whose partner plans to pregnant during the study period
•3\. Patients who are pregnant, nursing or possibly pregnant
•4\. Patients who are different for the participation in the study by complication of mental disease or psychiatric symptom.
•5\. Patients with pulmonary disorders such as interstitial pneumonia, active radiation pneumonitis or drug\-induced pneumonia
•6\. Patients with intestinal paralysis and ileus
•7\. Patients unable to swallow oral medications
•8\. Patients with infectious disorder need for intravenous injection of antibacterial drug and antimycotics
•9\. Patients with spinal cord compression, or unstable brain metastasis accompanying symptoms (however, the participation is possible if neurological function is clinically stable by radical cure treatment and more than 14 days passed after the secession of steroid therapy)
•10\. Patients with uncontrollable diabetes mellitus(eligible when control is considered good even if insulin is used continuously)