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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010090
Receipt No. R000011766
Scientific Title Phase I study of Erlotinib and Crizotinib after ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer
Date of disclosure of the study information 2013/02/21
Last modified on 2019/02/26

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Basic information
Public title Phase I study of Erlotinib and Crizotinib after ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer
Acronym Phase I study of Erlotinib and Crizotinib after ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer
Scientific Title Phase I study of Erlotinib and Crizotinib after ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Makot Nishio
Organization Cancer institute hospital, Japanese Foundation For Cancer Reseach
Division name Medical thoracic oncology
Zip code
Address Kouto-ku ariake 3-8-31, Tokyo, Japan
TEL 03-3520-0111
Email mnishio@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keita Kudo
Organization Cancer institute hospital, Japanese Foundation For Cancer Reseach
Division name Medical thoracic oncology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2012 Year 12 Month 13 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000011766

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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