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临床试验/JPRN-jRCTs071190015
JPRN-jRCTs071190015已完成2 期

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 个研究点目标入组 41 人开始时间: 2019年7月8日最近更新:
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适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
41
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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%).

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 20age old 至 ot applicable（—）
性别
All

入选标准

  • •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
  • •White blood cell count>= 3.0x10^3/uL -12.0x10^3/uL
  • •Neutrophil count >= 1.5x10^3/uL
  • •Platelet count >= 100x10^3/uL
  • •Hemoglobin >= 9.0 g/dl
  • •AST <= 100 IU/L
  • •ALT<= 100 IU/L
  • •Total bilirubin <= 1.5xULN
  • •creatinine <= 1.5xULN
  • •SpO2 (Room air)>=90%
  • •9. Patients whose following period after prior treatment passed in the planned starting point of administration (eligible from the same day after passed period)
  • •Chemotherapy: passed >= 2 weeks after the final administration
  • •EGFR-TKI: the next day after the last administration if there is no skin adverse event attributable to ore-treatment of EGFR-TKI or it is improved by <= Grade 1 of skin adverse event
  • •Radiation therapy in the case of chest radical irradiation: passed >= 4 weeks after the day of final radiation
  • •10. Patients providing the written informed consent

排除标准

  • •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)
  • •11. Patients with history of hypersensitivity to drugs (skin moisture, sunscreen, topical steroid for external use) and tetracycline agent used in this study
  • •12. Patients who have complications to be clinical problem
  • •(Such as sever or uncontrollable systemic disease)
  • •uncontrollable hypertension
  • •complication of unstable angina pectoris (angina pectoris onset within latest 3 weeks or with progression of spasm) or anamnesis of myocardial infarction within 6 months
  • •severe cardiac arrhythmia to need medical treatment
  • •sustained watery diarrhoea
  • •active bleeding
  • •13. Any other patients who are regarded as unsuitable for this study by the investigators.

研究者

发起方
Takayama Koichi

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