UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008485 |
|---|---|
| Receipt number | R000009976 |
| Scientific Title | A phase I study of SMP-105 (BCG-CWS) in patients with advanced cancers refractory to the standard treatment |
| Date of disclosure of the study information | 2012/07/25 |
| Last modified on | 2013/01/24 15:16:18 |
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Basic information
Public title
A phase I study of SMP-105 (BCG-CWS) in patients with advanced cancers refractory to the standard treatment
Acronym
A phase I study of SMP-105 (BCG-CWS)
Scientific Title
A phase I study of SMP-105 (BCG-CWS) in patients with advanced cancers refractory to the standard treatment
Scientific Title:Acronym
A phase I study of SMP-105 (BCG-CWS)
Region
| Japan |
Condition
Condition
Malignant tumors
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the maximum tolerated dose (MTD), the dose-limiting toxicity (DLT) and the recommended dose (RD) of SMP-105 in patients with advanced cancer refractory to the standard treatment.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Safety: Profile of adverse events, maximum tolerated dose (MTD), dose limiting toxicity (DLT), and recommended dose (RD).
Key secondary outcomes
Quality of life (QOL), induction of interferon-gamma, and tuberculin skin test.
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
Intradermal injection of 50 microgram SMP-105, weekly, four cycles
Interventions/Control_2
Intradermal injection of 100 microgram SMP-105, weekly, four cycles
Interventions/Control_3
Intradermal injection of 200 microgram SMP-105, weekly, four cycles
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) Patients with histologically confirmed malignant tumors.
2) Patients with malignant tumors refractory to standard therapy or without any hope of its efficacy.
3) Patients without any prior therapies (surgery, radiotherapy, chemotherapy, hyperthermia, other immunotherapy, and so on) for at least two weeks and without their influence.
4) Patients aged 20 to 75 years old.
5) Patients with at least three-month estimated life expectancy.
6) Patients with ECOG performance status of 0 to 2.
7) Adequate major organ functions and meeting the criteria below:
White blood cell counts >= 3,000/mm3
Absolute neutrophil counts >= 1500/mm3
Platelet counts >= 100,000/mm3
Hemoglobin >= 8.0 g/dL
AST and ALT <= 2 times the upper limit of normal
Serum bilirubin <= 1.5 times the upper limit of normal
Serum creatinine <= 1.5 times the upper limit of normal
No serious abnormal ECG
8) All patients are required to provide written informed consent.
Key exclusion criteria
1) Patients with severe complications infectious disease, interstitial pneumonitis, cardiac disease, renal disease, hepatic disease, and uncontrolled diabetes mellitus.
2) Patients with autoimmune disease (scleroderma, Sjogren's syndrome syndrome, idiopathic thrombocytopenic purpura, multiple sclerosis, rheumatoid arthritis, and so on).
3) Patients who need the treatment with corticosteroids and immunesuppressive agents during this study (The use of their local and inhaled administration and non-steroidal anti-inflammatory agents is permitted).
4) Pregnant, lactating, or potentially to be pregnant.
5) Patients judged inappropriate for this study by responsible investigators.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Yokokawa |
Organization
Kobe Haborland Immunotherapy Clinic
Division name
Clinic director
Zip code
Address
Kobe Harborland Center Building 14F, 1-3-3, Higashi Kawasakimachi, Chuo-ku, Kobe, Hyogo, 650-0044, Japan
TEL
078-360-3313
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Yokokawa |
Organization
Kobe Haborland Immunotherapy Clinic
Division name
Clinic director
Zip code
Address
Kobe Harborland Center Building 14F, 1-3-3, Higashi Kawasakimachi, Chuo-ku, Kobe, Hyogo, 650-0044
TEL
078-360-3313
Homepage URL
Sponsor or person
Institute
Kobe Haborland Immunotherapy Clinic
Institute
Department
Personal name
Funding Source
Organization
NPO the Supporting Center for Clinical Research and Education
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
神戸ハーバーランド免疫療法クリニック (兵庫県)
堂島リーガクリニック(大阪府)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 25 | 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
| 2012 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 21 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 21 | Day |
Date trial data considered complete
| 2013 | Year | 01 | Month | 21 | Day |
Date analysis concluded
| 2013 | Year | 01 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 20 | Day |
Last modified on
| 2013 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009976
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