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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016790
Receipt No. R000019489
Scientific Title A Phase I study of intratumoral administration of TDM-812 in patients with treatment-resistant breast cancer (RPN2siRNA)
Date of disclosure of the study information 2015/03/13
Last modified on 2018/03/30

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Basic information
Public title A Phase I study of intratumoral administration of TDM-812 in patients with treatment-resistant breast cancer (RPN2siRNA)
Acronym A Phase I study of intratumoral administration of TDM-812 in patients with treatment-resistant breast cancer(RPN2siRNA)
Scientific Title A Phase I study of intratumoral administration of TDM-812 in patients with treatment-resistant breast cancer (RPN2siRNA)
Scientific Title:Acronym A Phase I study of intratumoral administration of TDM-812 in patients with treatment-resistant breast cancer(RPN2siRNA)
Region
Japan

Condition
Condition treatment-resistant breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1) To evaluate safety and torelability of intratumoral administration of TDM-812 (RPN2siRNA/A6K complex)
2) To determine the recommended dose of TDM-812 in intratumoral administration for future clinical use
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes safety and tolerability
Key secondary outcomes ratio of adverse events, local response rate (RECIST1.1)

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 TDM-812 is intratumorally administered weekly at each dose level.
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 Female
Key inclusion criteria [Disease characteristics]
1. Inoperable or relapse breast cancer
2. Histological confirmation of invasive breast cancer(e.g., invasive ductal carcinoma, and special types)
3. A treatment history of anthracycline (e.g., doxorubicin and epirubicin) and taxane (e.g., paclitaxel, docetaxel, and nab-paclitaxel) agents, irrespective of the type of combination or treatment order.

[Patient characteristics]
1. Provision of signed informed consent.
2. Patients aged >=20 years women.
3. Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2.
4. Having at least one palpable lesion with which to evaluate objective response, based on the New RECIST guideline ver.1.1
5. Having lesions applicable to 4) which to be able to inject investigational drug
6. Having lesions applicable to 4) which to be able to conduct repeated biopsy
7. Patients with the following values in their latest laboratory tests, conducted within 7 days prior to the enrollment
-Neutrophil count >=1,000/mm3
-Platelet count >=75,000/mm3
-Total bilirubin <=1.5 mg/dL*ULN
-Serum ALT and AST <=100 U/dL (<=150 U/dL for patients with hepatic metastasis)
-Serum creatinine <=1.2 mg/dL
-ECG Normal or minimal changes not requiring treatment
(ECG measurement may be performed within 28 days prior to the enrollment).
8. Recovery to grade <=1 from all toxicities related to chemotherapy and radiotherapy, except for stable grade <=2 sensory neuropathy and alopecia.
9. In case of fertile woman, Patients fulfilled the following condition
a)not performed sex within 30 days before enrollment
b)provision of consent to conduct effective contraception from study enrollment to 6 months after study discontinuation.
Key exclusion criteria 1. Patients who meet the following conditions.
a)Patients who received other investigational drug(s) within 4 weeks before enrollment
b)Patients who received systemic therapy within 3 weeks before enrollment
c)Patients who received surgery within 4 weeks before enrollment
d)Patients who received radiation in wide area within 4 weeks before enrollment or received palliative radiation within 2 weeks before enrollment
e)Patients who have received radiation to planned lesion of administration of investigational drug
2. Patients with brain metastasis, except for patients who have completed topical therapy and stopped treatment with glucocorticoid agents at least 4 weeks before enrollment. For these patients, stable disease must be confirmed by symptoms and the images at the time of enrollment compared to the one obtained at least 4 weeks before enrollment..
3. Patients with systemic active infection.
4. Patients with active infection at planned lesions of administration of investigational drug.
5. Patients with allergy to local anesthetic
6. Patients with respiratory failure requiring oxygen inhalation therapy
7. Patients requiring anti-coagulant therapy
8. Patients with serious cardiovascular disease (congestive cardiac failure within 6 months before enrollment, history of unstable angina or myocardial infarction, or serious arrhythmia)
9. Patients with difficulty following the study procedures due to psychiatric disease or psychological symptoms
10. Patients who meet the following conditions.
a)HBs-Ag positive
(In case HBs-Ag is negative but HBs-Ab and/or HBc-Ab are/is positive, only HBV-DNA negative can be allowed to enroll.)
b)HCV-Ab positive and/or HCV-RNA positive
c)HIV-Ab positive
11. Pregnant or breast-feeding women, or women of child bearing potential who intend to become pregnant
12. Patients who should not participate in the study, as judged by the investigator(s)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Tamura
Organization National Cancer Center Hospital
Division name breast cancer and medical oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL 03-3542-2511-7390
Email ketamura@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ritsuko Nagasaka
Organization National Cancer Center Center for Research Administraion and Support
Division name Research Management Section
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL 03-3542-2511-5661
Homepage URL
Email RPN2-office@ml.res.ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) 3D Matrix Co, Ltd.

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 国立がん研究センター中央病院

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Completed
Date of protocol fixation
2015 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 18 Day
Last follow-up date
2017 Year 07 Month 31 Day
Date of closure to data entry
2017 Year 07 Month 31 Day
Date trial data considered complete
2017 Year 09 Month 30 Day
Date analysis concluded
2017 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 13 Day
Last modified on
2018 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019489

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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