UMIN-CTR Clinical Trial

Public title

An Investigator Initiative Trial of STNM01 by EUS-FNI to investigate the safety and efficacy in patients with unresectable pancreatic cancer

Acronym

An Investigator Initiative Trial of STNM01 by EUS-FNI to investigate the safety and efficacy in patients with unresectable pancreatic cancer

Scientific Title

An Investigator Initiative Trial of STNM01 by EUS-FNI to investigate the safety and efficacy in patients with unresectable pancreatic cancer

Scientific Title:Acronym

An Investigator Initiative Trial of STNM01 by EUS-FNI to investigate the safety and efficacy in patients with unresectable pancreatic cancer

Region

Japan

Condition

Unresectable advanced pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the feasibility and safety of EUS-guided fine needle injection of STNM01

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Adverse effects and adverse drug reactions

Key secondary outcomes

Tumor responce
Palliative benefit
PFS(Long-term observation)
Plasma drug concentrations

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

STNM01 will be diluted with physiological saline. Study drug will be administered using EUS-FNI technique to the tumor lesion. The patients will be received 250 nM of STNM01. Eligible subjects will be admitted to the study site and receive a single dose of the study drug on Day 1. They will return to the study site for follow-up examinations 7 and 30 days after administration.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1)The subject has an unresectable diagnosed pancreatic cancer.
2)The subject has been treated before the screening tests by conventional drug(s) generally used to treat pancreatic cancer [e.g., Gemicitabine, S-1]. In the opinion of his primary doctor, the subject has experienced an insufficient response or resistance to the current conventional treatment. The insufficient response or resistance to the current treatment is also confirmed by the principal investigator of this study. The experiencing an "insufficient response or resistance" can be assessed at the primary doctors and principal investigator's discretion.
3)The subject has measurable disease. Patients must have clinically and/or radiographically documented measurable disease.
4)The subject has an ECOG performance status of 0~1.
5)The subjects age is 20 or older and under 65 at the time of informed consent.
6)The subject is able to intraoral intake.
7)The subject has fully organ function.
8)The subject signs and dates a written informed consent to participate in the study.

Key exclusion criteria

1)The subject has or has a history of serious cardiac, hematological or pulmonary disease, and is unsuitable, in the investigator's opinion, to participate in the study.
2)The subject has moderate to severe ascites and/or pleural effusion.
3)The subject has or has a history of metastatic brain tumor.
4)The subject has or has a history of multiple primary cancers.
5)The subject has a complication of serious infection that requires hospitalization.
6)The subject has a hepatic impairment or renal disorder, and is unsuitable, in the investigator's opinion, to participate in the study.
7)The subject has a bleeding tendency.
8)The subject has a history of clinically serious allergic symptom. "Serious" means an allergic symptom causing generalized hives, anaphylaxis or shock requiring hospitalization, when exposed to a specific antigen or drug.
9)The subject is currently participating or plans to participate in another clinical study during the course of this study.
10)The subject has any psychiatric or neurological disorder, and is unsuitable, in the investigator's opinion, to participate in the study.
11)The subject is incapable of or restricted to the protocol-directed examinations or procedures.
12)The subject is considered by the investigator, for any other reason, to be unsuitable for participating in this study.
13) For females: pregnancy or lactation

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Makoto Nishimura

Organization

Tokyo Metropolitan Geriatric Hospital

Division name

Department of gastrointestinal endoscopy

Zip code

Address

32-2, Sakae-chou, Itabashi-ku, Tokyo, Japan

TEL

03-3964-1141

Email

makoto_nishimura@tmghig.jp

Name of contact person

1st name
Middle name
Last name	Makoto Nishimura

Organization

Tokyo Metropolitan Geriatric Hospital

Division name

Department of gastrointestinal endoscopy

Zip code

Address

32-2, Sakae-chou, Itabashi-ku, Tokyo, Japan

TEL

03-3964-1141

Homepage URL

Email

makoto_nishimura@tmghig.jp

Institute

Tokyo Metropolitan Geriatric Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

東京都健康長寿医療センター（東京都）

Date of disclosure of the study information

2014

Year

06

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2014

Year

06

Month

11

Day

Date of IRB

Anticipated trial start date

2014

Year

06

Month

11

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

06

Month

05

Day

Last modified on

2014

Year

06

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016462