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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002500
Receipt No. R000003057
Scientific Title Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer
Date of disclosure of the study information 2009/09/30
Last modified on 2014/12/05

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Basic information
Public title Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer
Acronym Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer
Scientific Title Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer
Scientific Title:Acronym Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer
Region
Japan

Condition
Condition Unresectable Advanced and Recurrent Biliary Tract Cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of OTS102 in combination with Gemcitabine
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall Survival(OS)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 OTS102 1mL will be administered by subcutaneous injection on days,1,8,15 and 22 of each 28-day treatment cycles.
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days,1,8 and 15.
Time frame:Maximum 1.5years after enrollment.
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1)Diagnosed as biliary tract cancer which includes intrahepatic cholangiocarcinoma,extrahepatic cholangiocarcinoma,gallbladder cancer, ampulla of vater cancer,and histologically confirmed as adenocarcinoma or squamous cell carcinoma.
2)Advanced unresectable biliary tract cancer and recurrent biliary tract cencer. Having of measurable lesions must not be required. Presence/absence of measurable lesions is not considered, but confirm by diagnostic imaging test within 21 days before enrollment.
3)Patients must have human leukocyte antigen(HLA)-A*2402
4)Patients must be >=20 years old and <75 years old at the time of obtaining informed consent.
5)ECOG Performance Status must be 0 or 1.
6)Life Expectancy must be >=3 months.
7)The following criteria must be satisfied in laboratory tests conducted within 21 days befor resigtration.And G-CSF,Erythropoetin,Blood products and transfusion must be untried within 2weeks before it inspects.
-White blood cell count >= 3,500 /mm3, <=12,000/mm3
-Neutrophil count >=2,000 /mm3
-Hemoglobin >=9.0 g/dL
-Platelet count >=100,000 /mm3
-Total bilirubin <=2.0 mg/dL(to be permitted <3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice.Consecutive measurements of two times must fill this criteria. )
-AST <=150 IU/L
-ALT <=150 IU/L
-Serum Creatinine <=1.5 mg/dL
8)When the adjuvant therapy is enforced to biliary tract cancer,the use medicine is TS-1.The final administering day must be conducted at least 6 months before enrollment.
9)Patients with no previous treatment (radiotherapy, chemotherapy, etc.) for biliary tract cancer, except resection.
10)Laparotomy must be conducted at least 2 weeks before enrollment.*8)of chemotherapies is excluded.
11)Voluntarily signed the written consent form.
Key exclusion criteria 1)Prior treatment of OTS102 or KDR169.
2)Double cancer except carcinoma in situ or intramucosal cancer (history is contained).
3)Pancreatic cancer infiltrated into digestive tract with serious concern of bleeding.
4)cerebral metastasis is doubted.
5)Pleural effusion, ascites fluid, pericardial fluid and peritoneal dissemination.
6)Active infections (excluding hepatitis B and C).
7)Severe liver disorder or renal disorder, equivalent to CTCAE grade3 or greater.
8)Severe nervous disorder or mental disorder.
9)Uncontrolled diabetes mellitus.
10)Intestinal tract paralysis or possible.
11)Chronic and systemic treatment of steroid.
12)Interstitial pneumonia or pulmonary fibrosis (to be confirmed by chest X-ray within 21 days before enrollment).
13)History of myocardial infarction or brain infarction within 6 months before registration.
14)Evidence of bleeding diathesis or severe coagulopthy, or patients with those histories.
15)Need continuous medication of anticoagulant drug except aspirin
16)Uncontrolled hypertenstion.
17)Arrhythmia or heart failure that needs treatment.
18)Other serious complication.
19)Pregnant females or nursing mothers who can not stop lactation after the recruitment. Patients or partners, who don't attempt to doing contraception or lactation during the study period
20)Current paticipation in other drug clinical trials. (excluding the study, which doesn't need intervention)
21)As determined by the principal investigator or the sub-investigator the subject are not adequate to participate in the trial.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masami Sakai
Organization Research & Development division
Division name Clinical Development dept
Zip code
Address Kanagawa Science Park R&D D11F,3-2-1,Sakado,Takatsu-ku,Kawasaki City,Kanagawa Pref.213-0012 Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Research & Development division
Division name Clinical Development dept
Zip code
Address Kanagawa Science Park R&D D11F,3-2-1,Sakado,Takatsu-ku,Kawasaki City,Kanagawa Pref.
TEL
Homepage URL
Email

Sponsor
Institute Oncotherapy science,Inc.
Institute
Department

Funding Source
Organization FUSO Pharmaceutical Industries,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://2013.europeancancercongress.org/Scientific-Programme/Abstract-search?abstractid=6061
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 Completed
Date of protocol fixation
2009 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2013 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 15 Day
Last modified on
2014 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003057

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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