UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 1 study of sulfapyridine in patients with advanced gastric cancer.
Title of the study (Brief title)	SASP
Region	Japan

Condition
Condition	advanced gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To determine a recommend dose of SASP in patients with advanced gastric cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of dose limiting toxicity (DLT)
Key secondary outcomes	Adverse event : AE Response rate: RR Progression free survival: PFS pharmacokinetics: PK

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	SAPS 8 g a day are orally-administered daily in a 14-day period. The maximum dose is 16 g a day.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	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.
Key exclusion criteria	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.
Target sample size	6

Research contact person
Name of lead principal investigator	Toshihiko Doi
Organization	National Cancer Center Hospital East
Division name	Gastrointestinal Oncology Division
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL	04-7133-1111
Email	sasp_core@east.ncc.go.jp

Public contact
Name of contact person	Kouhei Shitara
Organization	National Cancer Center Hospital East
Division name	Gastrointestinal Oncology Division
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL	04-7133-1111
Homepage URL
Email	kshitara@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Health and Labor Sciences Research Grant
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	School of Medicine, Keio University RIKEN
Name of secondary funｄer(s)

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	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）

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 31 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 02 Month 26 Day
Anticipated trial start date	2013 Year 04 Month 08 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 03 Month 15 Day
Last modified on	2016 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000011927