UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Phase 1 study of sulfapyridine in patients with advanced gastric cancer.
Acronym
SASP
Scientific Title
Phase 1 study of sulfapyridine in patients with advanced gastric cancer.
Scientific Title:Acronym
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
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
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
| 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
sasp_core@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kouhei 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
kshitara@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 02 | Month | 26 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011927
