A study to look at how safe, how well the drug is accepted by the body and how the body deals with the drug when a combination of 5-ALA and SFCare given in different doses in Cancer Patients with Anemia brought on by Chemotherapy.
- Conditions
- Cancer Patients with Solid Tumors with Chemotherapy Induced AnemiaMedDRA version: 16.1Level: PTClassification code 10002034Term: AnaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2013-002645-11-GB
- Lead Sponsor
- SBI Pharmaceuticals Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1. Adult patients between 18 and 80 years old (inclusive) at Screening, with active solid tumors.
2. Received chemotherapy within 6 weeks of the first dosing of study drug for this trial.
3. Patients who are anticipated to receive 2 or more additional chemotherapy treatments during the study duration (following the first dosing and before the final dosing).
4. Anemia that is thought to be due to chemotherapy (Screening hemoglobin [Hb] between 9.0 g/dL and 11.0 g/dL, inclusive AND at least 1 g/dL less than the Hb prior to starting the current course of chemotherapy AND Hb =11 g/dL at the time of starting that course of
chemotherapy). Patients should not have been anemic Hb <11 g/dL at time of starting the current course of chemotherapy.
5. Adequate renal function and adequate hepatic function (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] =2.5 x upper limit of normal [ULN]); serum creatinine =1.5 x ULN; total bilirubin =1.5 x ULN these results should be at less than Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (patients with Gilbert’s Syndrome may be included).
6. Patients should not be iron deficient (Fe/total iron binding capacity [TIBC] x 100 should be over 15%).
7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1 at the time of Screening.
8. Male and female patients must practice effective contraception and females of childbearing potential must have a negative pregnancy test prior to enrolment.
9. Patient is informed of the nvestigational nature of this study and has given written, witnessed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18
1. Patients with non solid, bone marrow based tumors.
2. Patients with renal cancer or inflammatory breast cancer.
3. Patients who have received any red blood cell (RBC) transfusion within 28 days before randomization.
4. Patients diagnosed with hemochromatosis.
5. Patients who have received any erythropoiesis-stimulating agents (ESA) treatment within 3 months prior to Screening.
6. Patients who have received a bone marrow or stem cell transplant in the 6 months prior to Screening or planned during the study, or with planned stem cell harvest of bone marrow during the study.
7. Patients with a history of, or active pure red cell aplasia (PRCA).
8. Other underlying disorder, which could cause anemia (e.g., hematologic disorder, iron or vitamin B12 deficiency, or gastrointestinal bleeding) as detected with ongoing diagnostic tests or with obvious clinical evidence.
9. Planned elective surgery during the study where significant blood loss is expected.
10. Planned radiation treatment during the study.
11. Active, unstable systemic or chronic infection.
12. Severe, unstable, active chronic inflammatory disease (e.g. ulcerative colitis, peptic ulcer disease, rheumatoid arthritis).
13. Uncontrolled hypertension (diastolic blood pressure >100 mmHg).
14. Unstable angina or uncontrolled cardiac arrhythmia.
15. History of Cerebro-vascular Accident (CVA), Transient Ischemic Attack (TIA), Acute Coronary Syndrome (ACS) including unstable angina and myocardial infarction or other arterial thrombosis within 6 months before study enrolment.
16. History of Deep Venous Thrombosis (DVT) or Pulmonary Embolus (PE) within 12 months before study enrolment. Prior superficial thrombophlebitis is not an exclusion criterion.
17. Known positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS) status.
18. Positive serology for hepatitis B surface antigen or hepatitis C antibody.
19. Patient has known sensitivity to any erythropoietic agents, the investigational products (including iron) or its excipients to be administered during this study.
20. Any gastrointestinal disorder or past gastrointestinal surgery that could alter the absorption of orally administered compounds.
21. Patients who are unwilling to refrain from sun tanning or other bright light exposure for the duration of the study.
22. Patients who are pregnant or breast feeding.
23. Patients who are deemed otherwise not suitable for enrolment by the Investigator.
24. Patients with previous history of photosensitivity.
25. Patients who have acute or chronic types of porphyria or family history of porphyria.
26. Patients with hypersensitivity to 5-ALA or porphyrins.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method