Phase II Trial of SPP-003 for chemotherapy induced anemia

Phase 2

• Conditions: Chemotherapy induced anemia

• Registration Number: JPRN-UMIN000012812
• Lead Sponsor: Saitama Medical University International Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-10
• Study Completion: 2015-06-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified