UMIN-CTR Clinical Trial

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

Unresectable Advanced and Recurrent Biliary Tract Cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Overall Survival(OS)

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Oncotherapy science,Inc.

Institute

Department

Personal name

Organization

FUSO Pharmaceutical Industries,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

09

Month

30

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2009

Year

09

Month

15

Day

Last modified on

2014

Year

12

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003057