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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012812
Receipt No. R000014963
Scientific Title Phase II Trial of SPP-003 for chemotherapy induced anemia
Date of disclosure of the study information 2014/01/10
Last modified on 2016/03/09

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Basic information
Public title Phase II Trial of SPP-003 for chemotherapy induced anemia
Acronym 5-ALA-01
Scientific Title Phase II Trial of SPP-003 for chemotherapy induced anemia
Scientific Title:Acronym 5-ALA-01
Region
Japan

Condition
Condition Chemotherapy induced anemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of SPP-003 (combination drug of 5-Aminolevulinic Acid hydrochloride [5-ALA HCl] and Sodium ferrous citrate [SFC]) for chemotherapy induced anemia in conjunction with platinum-containing chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes A rate of the patients whose Hb value increased more than 1.0 g/dl compared with those at baseline .
Key secondary outcomes Efficacy:
A rate of the patients whose Hb value increased more than 2.0 g/dl compared with those at baseline
Transition of an amount of Hb value change
Hb value at the lowest point
Transition of Hb value
Transition of red blood cell
Transition of peripheral blood reticulocyte count
Safety:
A incidence of adverse events
Changes of PS
Tolerability:
Drug adherence of investigational medicinal product

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 5-ALA HCl:300:mg/day(150mg/Capsule twice daily)
SFC:470:mg/day(235mg/Capsule twice daily)
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 Male and Female
Key inclusion criteria 1.Patients equal to or more than 20 years old with active solid tumors at registration
2.Patients received chemotherapy within 6 weeks prior to the expected date of the first dosing of investigational medical products for this trial
3.Patients anticipated to receive 2 or more additional platinum based chemotherapy treatment during the study duration
4.Patients with chemotherapy induced anemia whose laboratory data before registration meet all of the followings:
-Hemoglobin(Hb)should be lower more than 1.0 g/dL, compared with that of before the chemotherapy
-Screening hemoglobin (Hb)<=10.0 g/dL
5.Patients with adequate renal function and adequate hepatic function whose laboratory data at screening meet all of the followings:
-Serum creatinine<=1.5*ULN
-AST(GOT), ALT(GPT)<=ULN*3.0
-Total bilirubin<=ULN*1.5
6.Patients should not be iron deficient (Saturation of transferring =Serum iron (Fe)/total iron binding capacity (TIBC)*100 should be over 15%)
7.ECOG Performance Status:0-2 at registration
8.Female patients with childbearing potential who have negative pregnancy test at registration, and both male and female patients who agree to use contraception during the study
-Female patients who are of non-child bearing potential will not be required to undergo pregnancy test
9.Patients who is informed of the nature of this study and provide written informed consent for participation in this trial


Key exclusion criteria Patients with/who
1. bone marrow based tumors
2. renal cancer or inflammatory breast cancer
3. have currently or a history of hemochromatosis
4. have a medical history of PRCA or currently having active PRCA
5. have other underlying disorder which could cause anemia
6. have active chronic inflammatory disease
7. an active infection
8. have hypertension
9. have cardiac arrhythmia
10. have had any of the a following medical history
-within 6 months before registration:CVA, TIA, ACS
-within 12 months before registration:DVT(except well controlled DVT), PE, Other AT
11. Patients who have received RBC transfusion within 28 days before registration
12. Patients who have received ESA treatment within 3 months before registration
13. have received a bone marrow or stem cell transplantation before registration, or who are planned to receive a bone marrow, stem cell transplantation or stem cell harvest of bone marrow during the study.
14. are planned to undergo surgery which is expected to cause significant blood loss during the study
15. are planned to receive radiation treatment during the study
16. are known to be HIV positive or who have AIDS
17. are positive for either hepatitis B surface antigen or hepatitis C antibody
18. are known to have a hypersensitivity to any of the followings:
-Investigational medical products or its excipient
-porphyrin
19. have gastrointestinal disorder or the history of gastrointestinal surgery that could possibly alter the absorption of orally administered compounds
20. are breast feeding
21. a previous history of photosensitivity
22. have acute or chronic types of porphyria, or family history of porphyria
23. don't agree to refrain from sun tanning or other bright light exposure during the study
24. are deemed otherwise not suitable for enrolment by the Investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kosei Hasegawa, M.D.,Ph.D.
Organization Saitama Medical University International Medical Center
Division name Department of Gynecologic Oncology
Zip code
Address 1397-1 Yamane, Hidaka-City Saitama 350-1298
TEL 042-984-4531
Email koseih@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takaaki Takenaga
Organization 5-ALA Coordinating Center
Division name Clinical Trial Coordinating Center, Kitasato Academic Research Organization,
Zip code
Address 5-9-1 Shirokane Minato-Ku Tokyo 108-8642 JAPAN
TEL 03-5791-6398
Homepage URL
Email ala_a@insti.kitasato-u.ac.jp

Sponsor
Institute Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization SBI Pharmaceuticals Co., 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 初回届出年月日:20131206 届出回数:1

Institutions
Institutions 埼玉医科大学国際医療センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 10 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
Among the 19 registered patients, 17 patients were administered with SPP-003.
In using SPP-003 twice a day after breakfast and dinner, during the course of 8 weeks while undergoing chemotherapy, it was considered that there was neither any problem in safety nor regarding in tolerability.
Regarding the effectiveness of the primary endpoint (FAS), in comparison to the baseline at the final evaluation, for the frequency of cases (Rate, 95%CI) in which the value of Hb increased by more than 1.0 g/dl , among was 4 of the 16 cases (Rate;25.0%, 95%CI; 7.3% to 52.4%), and the one-sided and two-sided P-values were 0.1030 and 0.2061, respectively.
Based on the results of this small single-arm open study, a comparative study should be designed for future efficacy analysi.
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
2013 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 27 Day
Last follow-up date
2015 Year 06 Month 14 Day
Date of closure to data entry
2015 Year 06 Month 30 Day
Date trial data considered complete
2015 Year 09 Month 30 Day
Date analysis concluded
2015 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 10 Day
Last modified on
2016 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014963

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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