Unique ID issued by UMIN | UMIN000010254 |
---|---|
Receipt number | R000011927 |
Scientific Title | Phase 1 study of sulfapyridine in patients with advanced gastric cancer. |
Date of disclosure of the study information | 2013/03/31 |
Last modified on | 2016/04/12 08:55:34 |
Phase 1 study of sulfapyridine in patients with advanced gastric cancer.
SASP
Phase 1 study of sulfapyridine in patients with advanced gastric cancer.
SASP
Japan |
advanced gastric cancer
Gastroenterology |
Malignancy
YES
To determine a recommend dose of SASP in patients with advanced gastric cancer.
Safety
Frequency of dose limiting toxicity (DLT)
Adverse event : AE
Response rate: RR
Progression free survival: PFS
pharmacokinetics: PK
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
SAPS 8 g a day are orally-administered daily in a 14-day period. The maximum dose is 16 g a day.
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically or cytologically proven gastric adenocarcinoma or gastro-esophageal junction adenocarcinoma.
2) Preserved tumor specimen or biopsy specimens are available before this therapy, and biopsy specimens are considered to be available after 1 course of this therapy.
3) Prior chemotherapies for advanced gastric cancer and recurrent gastric cancer meet the criteria as follows. (In case of progression during adjuvant/neoadjuvant therapy or <= 6 months after the last administration of adjuvant/neoadjuvant therapy, the adjuvant/neoadjuvant therapy will be considered one regimen.)
i. Chemotherapy include fluorinated pyrimidine.
ii. Chemotherapy include platinum derivative.
iii. Chemotherapy include taxane.
iv. Chemotherapy include Irinotecan.
4) >= 20 years old.
5) ECOG Performance Status of 0-1, or 2.
6) Adequate organ function. i.e. meet all criterion as follows.
i. Absolute neutrophil count >= 1,500 /mm3
ii. hemoglobin >= 8.0 g/dL
iii. Platelet count >= 75,000 /mm3
iv. Total bilirubin <= 2.0 mg/dL
v. AST <= 100 IU/L or <= 150 IU/L with liver metastasis.
vi. ALT <= 100 IU/L or <= 150 IU/L with liver metastasis.
vii. serum creatinine <= 2.0 mg/dL
7) No blood transfusion within 14 days prior to enrollment.
8) AE related to prior treatment must be Grade <= 1 according to CTCAE. (except alopecia, peripheral sensory neuropathy, skin hyperpigmentation and dysgeusia)
9) Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment.
10) Adequate oral intake.
11) Written informed consent.
1) Chemotherapy, radiation therapy or other investigational drugs within 2 weeks prior to enrollment.
2) Active bleeding.
3) Patient with any of the following symptoms within 6 months prior to administration of the drug; myocardial infarction, severe or unstable angina, congested heart failure, cerebrovascular accident containing transient ischemic attack or pulmonary embolism.
4) Uncontrolled bronchial asthma.
5) Patient with brain metastases.
6) Laparotomy or thoracotomy within 4 weeks to enrollment.
7) Known hypersensitivity to sulfa drugs or acetylsalicylic acid formulation.
8) Women during pregnancy or lactation, women suspected of being pregnant, women desiring future fertility.
9) Patient is judged by the investigator to be inappropriate for study participation for any reason.
10) Patient with Ulcerative colitis, or treated patient with sulfapyridine or 5-ASA derivative.
6
1st name | |
Middle name | |
Last name | Toshihiko Doi |
National Cancer Center Hospital East
Gastrointestinal Oncology Division
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
04-7133-1111
sasp_core@east.ncc.go.jp
1st name | |
Middle name | |
Last name | Kouhei Shitara |
National Cancer Center Hospital East
Gastrointestinal Oncology Division
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
04-7133-1111
kshitara@east.ncc.go.jp
National Cancer Center Hospital East
Health and Labor Sciences Research Grant
Japanese Governmental office
Japan
School of Medicine, Keio University
RIKEN
NO
独立行政法人国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
聖マリアンナ医科大学病院(神奈川県)
公益財団法人がん研究会有明病院(東京都)
2013 | Year | 03 | Month | 31 | Day |
Published
Main results already published
2013 | Year | 02 | Month | 26 | Day |
2013 | Year | 04 | Month | 08 | Day |
2015 | Year | 03 | Month | 31 | Day |
2013 | Year | 03 | Month | 15 | Day |
2016 | Year | 04 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011927