UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of Erlotinib and Crizotinib after ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer
Title of the study (Brief title)	Phase I study of Erlotinib and Crizotinib after ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer
Region	Japan

Condition
Condition	ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objectives of this study is To determine the recommend dose of Erlotinib and Crizotinib, and to investigeate the efficacy and safety of the recommend dose for Erlotinib and Crizotinib after ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	safety
Key secondary outcomes	Response rate, disease control rate, progression free survival, overall Survival,

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Erlotinib and Crizotinib combinationtherapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Non-small cell lung cancer proven by histology and/or cytology and ALK positive lung cancer by IHC or FISH or RT-PCR. 2))Patients who have previously treated with ALK inhibiter more than 3 weeks and 3) With one or more measurable disease based on RECIST (ver.1.1) 4) Performance Status (ECOG) : 0-1 5) 20<= years 6) Patients providing written informed consent 7) Adequate function of vital organs, including normal hematopoietic liver and renal function as following: WBC >= 3,000/mm3 or Neutrophils >= 1,500/mm3 Hemoglobin >= 9.0 g/dL Platelets >= 100,000/mm3 AST and ALT, x 2.5 of upper limit of normal (ULN) or less. Total bilirubin <= 1.5mg/mL Serum creatinine <= 1.5mg/dL Creatinin crealance>=30mL/min PT-INR <1.5 Urinary protein <2+ PaO2>=60torr or SpO2>=95% 8)interval: (1) chemotherapy, more than 3 weeks after the last chemotherapy. (2) Radiation, more than 12 weeks after the thoracic irradiation or more than 2 weeks after the last irradiation to other organs. (3) Operation, more than 4 weeks after the last operation (including pleurodesis) 9) A life expectancy of more than 3 months
Key exclusion criteria	1)No prior treatment with EGFR-TKI 2)Patients with uncontrollable complications(e.g. uncontrollable heart disease, severe arrhythmia, continuous diarrhea). 3)Patients with active severe brain metastasis. 4)1)Interstitial pneumonia or pulmonary fibrosis detectable on X ray. 5)History of active double cancer within 5 years prior to the study. 6)Patients with symptomatic brain metastasis 7)Impossible cases with oral administration. 8)Pregnancy or lactation 9) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	Makot Nishio
Organization	Cancer institute hospital, Japanese Foundation For Cancer Reseach
Division name	Medical thoracic oncology
Address	Kouto-ku ariake 3-8-31, Tokyo, Japan
TEL	03-3520-0111
Email	mnishio@jfcr.or.jp

Public contact
Name of contact person	Keita Kudo
Organization	Cancer institute hospital, Japanese Foundation For Cancer Reseach
Division name	Medical thoracic oncology
Address	Kouto-ku ariake 3-8-31, Tokyo, Japan
TEL	03-3520-0111
Homepage URL
Email	keita.kudo@jfcr.or.jp

Sponsor
Institute	Medical thoracic oncology, Cancer institute hospital, Japanese Foundation For Cancer Reseach
Institute
Department

Funding Source
Organization	Medical thoracic oncology, Cancer institute hospital, Japanese Foundation For Cancer Reseach
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 21 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 12 Month 13 Day
Anticipated trial start date	2013 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 02 Month 21 Day
Last modified on	2019 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011766