Cancer Patients with Solid Tumors with Chemotherapy Induced Anemia MedDRA version: 16.1 Level: PT Classification code 10002034 Term: Anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: 5-ALA HCl 50 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: 5-aminolevulinic acid hydrochloride (5-ALA HCl)
CAS Number: 5451-09-2
Other descriptive name: 5-Amino-4-oxopentanoic aci
Sponsors
SBI Pharmaceuticals Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety, tolerability and pharmacokinetics of two multiple oral dose levels of 5-aminolevulinic acid (5-ALA) and sodium ferrous citrate (SFC) given in cancer patients with solid tumors with chemotherapy induced anemia (CIA). ;Secondary Objective: To assess pharmacodynamic responses of orally 5-ALA and SFC administered to cancer patients with solid tumors with CIA.;Primary end point(s): -Safety and Tolerability Assessments: 1. Adverse Events 2. Vital Signs: Blood presure and pulse rate and oral body temperature 3. 12-Lead Electrocardiogram 4. Clinical Laboratory Evaluations: Clinical Chemistry, Hematology, Urinalysis. 5. Glomerular Filtration Rate 6. Fecal Occult Blood 7. Physical Examination 8. Body Weight 9. Functional Assessment of Cancer Therapy Anemia (FACT-An) -Pharmacokinetics Clinical Laboratory analysis ;Timepoint(s) of evaluation of this end point: -Safety and Tolerability 1.Scr, w0,w1, w2, w4, w6, w8, Post. 2. -Blood presure and pulse rate: Scr, w0-predose to postdose, w1, w2, w4, w6, w8, Poststudy. -Oral body temperature: Scr, w4, Poststudy. 3. Scr, w4, Poststudy. 4. - Clinical Chemistry: Scr, w0 predose, w2, w4, w6, w8, Poststudy. - Hematology: Scr, w0 predose, w1, w2, w4, w6, w8, Poststudy. - Urinalysis: Scr, w2, w4, w8, Poststudy. 5.W0-predose,w2, w4, w6, w8, Poststudy. 6.Scr. 7.Scr, w4,Poststudy. 8.Scr, w0, w1, w2, w4, w6, w8, Poststudy. 9. w0-predose, w2, w4, w6, w8. -Pharmacokinetics Clinical Laboratory analysis -5-ALA in plasma: Scr, w0 (Day 1) predose to 8h postdose. -5-ALA urine: day 1 predose to postdose, w4, w8, Poststudy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Pharmacodynamics. Clinical Laboratory analysis ;Timepoint(s) of evaluation of this end point: -Pharmacodynamics. Clinical Laboratory analysis: -Blood sampling for porphyrin, HO-1: Scr, Day 1 predose to postdose. - Urine for porphyrin, porphobilinogen: Day 1 predose to postdose, w4, w8, Poststudy. - Blood sampling for iron, TIBC, UIBC, ferritin, transferrin: Scr, w0-predose, w4, w8, Poststudy. Exploratory Biomarkers: Hepcidin, Erythropoietin, eGFR, Interleukin-6, TNF alpha: w0-predose, w2, w4, w6, w8, Poststudy. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Development Department
SBI Pharmaceuticals Co., Ltd
Outcome results
None listed