Chemotherapy induced anemia
Conditions
Interventions
5-ALA HCl:300:mg/day(150mg/Capsule twice daily) SFC:470:mg/day(235mg/Capsule twice daily)
Sponsors
Saitama Medical University International Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A rate of the patients whose Hb value increased more than 1.0 g/dl compared with those at baseline . | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTakaaki Takenaga
5-ALA Coordinating Center Clinical Trial Coordinating Center, Kitasato Academic Research Organization,
Outcome results
None listed