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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009867
Receipt No. R000011047
Scientific Title Pharmacokinetic study of crizotinib in Japanese patients with ALK fusion gene positive Non-small cell carcinoma
Date of disclosure of the study information 2013/01/31
Last modified on 2020/01/04

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Basic information
Public title Pharmacokinetic study of crizotinib in Japanese patients with ALK fusion gene positive Non-small cell carcinoma
Acronym Pharmacokinetic study of crizotinib
Scientific Title Pharmacokinetic study of crizotinib in Japanese patients with ALK fusion gene positive Non-small cell carcinoma
Scientific Title:Acronym Pharmacokinetic study of crizotinib
Region
Japan

Condition
Condition ALK fusion gene positive NSCLC
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate pharmacokinetics of Crizotinib in Japanese patients with ALK fusion gene positive NSCLC.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate the correlation PK/PD with effects and adverse events of Crizotinib.
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 Other
Interventions/Control_1 We evaluate pharmacokinetics of Crizotinib.
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.The patient diagnosed as ALK fusion gene positive Non-small cell lung cancer with histological or cytological diagnosis
2.The recurrence and progressive Non-small cell lung cancer which is unresectable
3.The patient who is going to take Crizotinib 250mg twice a day
4.A patiet at least 20 years at the registration within 14 day before registration
5.Laboratory data within 14 days fill following all, total bilirubin : 2.0 or less mg/dl, AST (GOT) : 150 or less IU/L, ALT (GPT) : 150 or less IU/L, serum creatinine : 2.0 or less mg/dL, SpO2 : 90 or more % (room air)
6.The patient has provided signed informed consent

Key exclusion criteria 1. The patients need to concurrent treatment with other anticancer therapy, including other chemotherapy, radiotherapy, or immunotherapy.
2. Preexisting interstitial lung disease (ILD)
3. Known positive test results for human immunodeficiency virus (HIV),hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCVb)
4. The digestive disorder which influences absorption of Crizotinib, malabsorption syndrome, gastric resection including stomach subtotal excision, or extensive small intestine resection.
5. Oral feeding difficulty
6. The pregnant patient, patient suspected of being pregnant, or breastfeeding.
7. The patient whom the principal investigator or the doctor in attendance judged not to be suitable as an experimental object
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Tomohide
Middle name
Last name Tamura
Organization National Cancer Center Hospital
Division name Thoracic Oncology
Zip code 104-0045
Address Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL 03-3542-2511
Email ttamura@ncc.go.jp

Public contact
Name of contact person
1st name Yutaka
Middle name
Last name Fujiwara
Organization National Cancer Center Hospital
Division name Thoracic Oncology
Zip code 104-0045
Address Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL 03-3542-2511
Homepage URL
Email yutakafu@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization National Cancer Center Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization National Cancer Center Hospital
Address Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN
Tel 03-3542-2511
Email yutakafu@ncc.go.jp

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 国立がん研究センター中央病院(東京都)/ National Cancer Center Hospital(Japan)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 31 Day

Related information
URL releasing protocol https://onlinelibrary.wiley.com/doi/full/10.1111/cas.12983
Publication of results Published

Result
URL related to results and publications https://onlinelibrary.wiley.com/doi/full/10.1111/cas.12983
Number of participants that the trial has enrolled 8
Results
In pharmacokinetic analysis, blood samples were obtained on days 1 and 15. The mean area under the plasma concentration-time curve on day 15 was significantly increased in patients with clinically significant AEs compared with those without (P=0.04). 
Results date posted
2020 Year 01 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Inclusion criteria were advanced ALK positive NSCLC scheduled for treatment with crizotinib therapy.
Participant flow
From March 2013 to June 2014, a total of eight patients were enrolled.
Adverse events
All patients experienced at least one AE of any grade of toxicity, and five patients experienced clinically significant AEs. We were able to manage these AEs with supportive care and reduced doses in seven patients.
Outcome measures
PK analysis and toxicity
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 02 Month 06 Day
Date of IRB
2013 Year 02 Month 06 Day
Anticipated trial start date
2013 Year 02 Month 27 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 01 Month 25 Day
Last modified on
2020 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011047

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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