UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008336
Receipt number R000009813
Scientific Title Phase1 Clinical Trial of OTS102 in Subjects with Solid Tumors
Date of disclosure of the study information 2012/07/09
Last modified on 2014/12/05 14:59:14

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Basic information

Public title

Phase1 Clinical Trial of OTS102 in Subjects with Solid Tumors

Acronym

Phase1 Clinical Trial of OTS102 in Subjects with Solid Tumors

Scientific Title

Phase1 Clinical Trial of OTS102 in Subjects with Solid Tumors

Scientific Title:Acronym

Phase1 Clinical Trial of OTS102 in Subjects with Solid Tumors

Region

Japan


Condition

Condition

Solid tumor

Classification by specialty

Medicine in general

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To establish the safety of OTS102 in subjects with solid tumors. In addition, this trial will guide decision making for dose selection in subsequent studies.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

The incidence of adverse event and Dose-Limiting Toxicity (DLT)

Key secondary outcomes

Efficacy (Tumor resuponse assessment based on the Response Evaluation Criteria in Solid Tumor [RECIST] guidelines)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

OTS102 0.5mg/mL will be administrated by sunjection Once a week at 4 times.
Transition to the next cohort will be decided following evaluation of the development of DLT.

Interventions/Control_2

OTS102 1.0mg/mL will be administrated by sunjection Once a week at 4 times.
Transition to the next cohort will be decided following evaluation of the development of DLT.

Interventions/Control_3

OTS102 2.0mg/mL will be administrated by sunjection Once a week at 4 times.

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)Patients with histologically or cytologically documented advanced solid tumors. Only for liver, biliary, or pancreas cancers, accept the diagnostic imaging technique.
2)Patients who are refractory to standard therapy or for which no standard therapy is available.
3)Age 20 years and older at the time of obtaining informed consent.
4)Eastern Cooperative Oncology Group (ECOG) Performance States (PS) of 0 to 1
5)Histocompatibility Locus Antigen (HLA)-A*2402
6)Life expectancy is 3 months or longer
7)Patients who are free of marked failure of major organ function.
8)Patients meeting the criteria of washing out period from the completion of the previous cancer treatment to the start date of OTS102.
9)Patients who can be hospitalized for the period provided for protocol.
10)Informed consent must be obtained.

Key exclusion criteria

1)symptomatic brain metastasis
2)pleural effusion, ascites fluid, pericardial fluid requiring drenege
3)Unhealed traumatic lesion
4)Hemorrhagic diathesis or severe coagulopthy, and patients with those histories
5)hemoptysis or lung hemorrhage or gastrointestinal bleeding, and patients with those histories
6)uncontrolled hypertension (systolic:140 mmHg and over, diastolic: 90 mmHg and over), or serious arrhythmia or heart failure
7)serious complication, equivalent to CTCAE grade 3 or greater
8)Patients who require systemic administration of the following agents during OTS102 study medication period.
-Corticosteroid, Anticoagulant drug, Immunosuppresant, Immunostimulant
-Granulocyte Colony Stimulating Factor (G-CSF), Granulocyte, Macrophage Colony Stimulating Factor (GM-CSF), Erythropoietin (EPO)
9)Participating in drug clinical trials
10)Woman who is pregnant, breast feeding and child-bearing potential.
11)Patient or patient's partner unwilling to use adequate contraception.
12)As determined by the principal investigator or the sub-investigator the subject has difficulties that would prevent the subject's ability to participate in the trial.

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuji Mukasa

Organization

OncoTherapy Science, Inc.

Division name

Clincal Development Dept.

Zip code


Address

Kanagawa Science Park R&D D11F, 3-2-1, Sakado, Takatsu-ku, Kawasaki City, Kanagawa Pref. Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

OncoTherapy Science, Inc.

Division name

Clinical Development Dept.

Zip code


Address

Kanagawa Science Park R&D D11F, 3-2-1, Sakado, Takatsu-ku, Kawasaki City, Kanagawa Pref. Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

OncoTherapy Science, Inc.

Institute

Department

Personal name



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

2012 Year 07 Month 09 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://onlinelibrary.wiley.com/doi/10.1111/cas.12014/pdf

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

2006 Year 03 Month 28 Day

Date of IRB


Anticipated trial start date

2006 Year 07 Month 01 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

2012 Year 07 Month 04 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=R000009813


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name