Unique ID issued by UMIN | UMIN000032725 |
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Receipt number | R000037313 |
Scientific Title | A prospective Single-center Study of Pharmacokinetics and Pharmacogenetics of Regorafenib in Patients with Metastatic Colorectal Cancer |
Date of disclosure of the study information | 2018/05/25 |
Last modified on | 2022/11/27 09:05:57 |
A prospective Single-center Study of Pharmacokinetics and Pharmacogenetics of Regorafenib in Patients with Metastatic Colorectal Cancer
Study of Pharmacokinetics and Pharmacogenetics of Regorafenib
A prospective Single-center Study of Pharmacokinetics and Pharmacogenetics of Regorafenib in Patients with Metastatic Colorectal Cancer
Study of Pharmacokinetics and Pharmacogenetics of Regorafenib
Japan |
Metastatic Colorectal Cancer
Gastroenterology |
Malignancy
YES
The aim of this study is to identify high risk patients who are more likely to have severe toxicity by evaluating the association among PK, SNPs, and Regorafenib-related severe toxicity.
Safety,Efficacy
Primary endpoint was to evaluate the association between SNPs of UGT1A9 and hand foot syndrome Grade 3.
Observational
Not applicable |
Not applicable |
Male and Female
The inclusion criteria are mainly as follows (regardless of gender):
1. Has adenocarcinoma of the colon or rectum
2. Metastatic colorectal cancer
3. ECOG performance status of 0-1
4. Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer (refractory or intolerant to standard chemotherapy with FUs, L-OHP, CPT-11, bevacizumab as anti-VEGF antibody and cetuximab/patitumumab as anti-EGFR antibody)
5. Is able to take medications orally
6. Survival for at least 12 weeks is expected.
7. On the basis of tests carried out within 14 days before enrollment, which may be on the same day of the week as the enrollment date but 2 weeks earlier, the principal organ functions are maintained, as defined by the following criteria:
a) Neurtophils>or=1500/mm3
b) Platelets>or=75,000/mm3
c) Hemoglobin>or=8.0g/dl
d) GOT(AST)=or<upper limit of normal (ULN)*2.5 (=or<ULN*5 in case of liver metastasis)
e) GPT(ALT) =or<upper limit of normal (ULN)*2.5 (=or<ULN*5 in case of liver metastasis)
f) Total bilirubin =or<upper limit of normal (ULN)*1.5
g) Serum creatinine =or<upper limit of normal (ULN)*1.5
8. Has provided written informed consent
The exclusion criteria are mainly as follows (regardless of gender):
1. Has synchronous multiple primary cancer within 5 years (except for carcinoma in situ )
2.Taking CYP3A4 inhibitors or inducers(eg, phenytoin, carbamazepine, rifampin, phenobarbital, ketoconazole, macrolide antibiotics).
3. Has complication as follows
a) poorly controlled diabetes
b) uncontrolled hypertensions
c) cirrhosis, liver failure, renal insufficiency
d) intestinal paralysis, ileus
e) interstitial lung disease, pulmonary fibrosis, emphysema
f) active infection
g) cardiac disease
h) cerebrovascular disorder, brain metastasis
i) hemorrhagic ulcer
J) psychiatric disorder
4. Is a pregnant or lactating female
5. Amalgamation of mental disease or psychotic manifestation
6. The investigator considers not suitable for the study
150
1st name | Kensei |
Middle name | |
Last name | Yamaguchi |
Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Department of Gastroenterological Chemotherapy
135-8550
3-8-31 Ariake, Koto-ku, Tokyo
+81-3-3520-0111
kensei.yamaguchi@jfcr.or.jp
1st name | Kazuo |
Middle name | |
Last name | Kobayashi |
Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Department of Pharmacy
135-8550
3-8-31 Ariake, Koto-ku, Tokyo
+81-3-3520-0111
kazuo.sugita@jfcr.or.jp
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Japanese Foundation for Cancer Research
Other
institutional review board,Cancer Institute Hospital of the Japanese Foundation for Cancer Research
3-8-31 Ariake, Koto-ku, Tokyo
+81-3-3520-0111
med.shinsa@jfcr.or.jp
NO
2018 | Year | 05 | Month | 25 | Day |
Unpublished
30
Main results already published
2018 | Year | 07 | Month | 25 | Day |
2018 | Year | 05 | Month | 24 | Day |
2018 | Year | 08 | Month | 01 | Day |
2024 | Year | 05 | Month | 24 | Day |
The aim of this study is to identify high risk patients who are more likely to have severe toxicity by evaluating the association among PK, SNPs, and Regorafenib-related severe toxicity .
2018 | Year | 05 | Month | 25 | Day |
2022 | Year | 11 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037313
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