UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009867 |
|---|---|
| Receipt number | 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 18:18:07 |
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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
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
yutakafu@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011047
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