UMIN-CTR Clinical Trial

Basic information
Public title	A phase 1 study of cisplatin/pemetrexed/crizotinib followed by maintenance crizotinib in patients with stage 3B or 4 EML4-ALK positive non-small-cell lung cancer.
Acronym	A phase 1 study of cisplatin/pemetrexed/crizotinib followed by maintenance crizotinib in patients with stage 3B or 4 EML4-ALK positive non-small-cell lung cancer.
Scientific Title	A phase 1 study of cisplatin/pemetrexed/crizotinib followed by maintenance crizotinib in patients with stage 3B or 4 EML4-ALK positive non-small-cell lung cancer.
Scientific Title:Acronym	A phase 1 study of cisplatin/pemetrexed/crizotinib followed by maintenance crizotinib in patients with stage 3B or 4 EML4-ALK positive non-small-cell lung cancer.
Region	Japan

Condition
Condition	Chemo-naïve advanced ALK positive NSCLC
Classification by specialty	Hematology and clinical oncology Adult
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To assess the safety of cisplatin and pemetrexed and crizotinib in patients with advanced ALK positive NSCLC
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Maximum Tolerated schedule of crizotinib with cisplatin and pemetrexed
Key secondary outcomes

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	cisplatin (75mg/m2) + pemetrexed (500mg/m2) level 1: crizotinib 200mg twice daily day1-7 level 2: crizotinib 250mg twice daily day1-7 level 3: criztotinib 250mg twice daily day1-14 level 4: crizotinib 250mg twice daily day 1-21 level 5: crizotinib 250mg twice daily
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)Histologically or cytologically confirned non-small-cell lung cancer (NSCLC) 2)Diagnosed EML4-ALK positive by Fish or PCR 3)With measurable lesion 4)Stage IIIB without any indications for radiotherapy or Stage IV or recurrent disease after surgery or radiotherapy who have no prior chemoterapy 5)20 years old or older 6)ECOG PS 0-1 or older 7)Adequate organ function 8)Life expectancy more than 3 months 9)Signed informed consent
Key exclusion criteria	1)Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray 2) History of poorly controlled pleural effusion,pericardial effusion and ascites 3)Not appropriate to receive the folic acid and vitamin B12 formulation 4)SVC syndrome 5)Symptomatic brain metastases 6)History of active double cancer 7)Uncontrollable diabetes mellitus and hypertension 8)Diagnosed as liver cirrhosis by image findings or clinical laboratory 9)Suffers from an infectious disease to need antibiotic treatment 10)History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,herat failure,etc within 6 months) 11)Pregnant female or sexually active males/females unwilling to use contraception during the protocol treatment 12)History of grave drug allergic reaction 13)Acute inflammatory disease 14)An agreement is not obtained for support therapy such as transfusion etc. 15)History of active psychological disease 16)Having the bleeding tendency which is clear in clinic 17)Taking continuous whole body administration (oral administration or intravenous administration) of steroid 18)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinji Atagi
Organization	National organization Kinki-chuo chest medical center
Division name	medical oncology
Zip code
Address	1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka591-8555 JAPAN
TEL	072-252-3021
Email

Public contact
Name of contact person	1st name Middle name Last name Kazuhiro Asami
Organization	National organization Kinki-chuo chest medical center
Division name	medical oncology
Zip code
Address	1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka591-8555 JAPAN
TEL	072-252-3021
Homepage URL
Email	asami@kch.hosp.go.jp

Sponsor
Institute	National organization Kinki-chuo chest medical center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2012 Year 11 Month 05 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	Open public recruiting
Date of protocol fixation	2012 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date	2012 Year 11 Month 05 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	2012 Year 11 Month 03 Day
Last modified on	2012 Year 11 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010868

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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