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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009256
Receipt No. R000010868
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.
Date of disclosure of the study information 2012/11/05
Last modified on 2012/11/03

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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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