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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015595
Receipt No. R000017850
Scientific Title Phase 1 study of cisplatin + sulfasalazine in patients with advanced gastric cancer.
Date of disclosure of the study information 2014/11/04
Last modified on 2016/04/12

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Basic information
Public title Phase 1 study of cisplatin + sulfasalazine in patients with advanced gastric cancer.
Acronym CDDP+SASP
Scientific Title Phase 1 study of cisplatin + sulfasalazine in patients with advanced gastric cancer.
Scientific Title:Acronym CDDP+SASP
Region
Japan

Condition
Condition advanced gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine a recommend dose of CDDP+SASP in CD44v positive 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

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 CDDP 60mg/m2 is administrated on day1 and SAPS 6 g /day are orally-administered daily in day 1-14. The maximum dose is 8 g a day.
1 cycle is 21days until progressive disease.
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)Histologically or cytologically proven gastric adenocarcinoma or gastro-esophageal junction adenocarcinoma.
2)Archival tumor specimen with CD44v positive before this therapy, and biopsy specimens are considered to be available before and after 1 course of this therapy.
3)Disease progression during or within 3 months after prior chemotherapy including cisplatin
4)>= 20 years old.
5)ECOG Performance Status of 0-1, or 2.
6)Adequate organ function. i.e. meet all criterion as follows.
Absolute neutrophil count>=1,500 /mm3
Hemoglobin >=8.0 g/dL
Platelet count>=75,000 /mm3
Total bilirubin <= 2.0 mg/dL
AST<=100 IU/L or <=150 IU/L with liver metastasis.
ALT<=100 IU/L or <=150 IU/L with liver metastasis.
Serum creatinine<=2.0 mg/dL or Creatinine clearance >=50 mL/min
7)No blood transfusion within 8 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)Known history of serious adverse events due to cisplatin
9)Women during pregnancy or lactation, women suspected of being pregnant, women desiring future fertility.
10)Patient is judged by the investigator to be inappropriate for study participation for any reason.
11)Patient with Ulcerative colitis, or treated patient with sulfapyridine or 5-ASA derivative.
Target sample size 18

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

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

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

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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東病院

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2014 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 11 Month 04 Day
Last modified on
2016 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017850

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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