UMIN-CTR Clinical Trial

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

Chemotherapy induced anemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

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

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

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

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

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

Institute

Saitama Medical University International Medical Center

Institute

Department

Personal name

Organization

SBI Pharmaceuticals Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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

初回届出年月日：20131206　届出回数：1

Institutions

埼玉医科大学国際医療センター（埼玉県）

Date of disclosure of the study information

2014

Year

01

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

01

Month

10

Day

Last modified on

2016

Year

03

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014963