EUCTR2013-002645-11-GB进行中（未招募）不适用
An Open-label, Randomized Study to Evaluate Safety, Tolerability and Pharmacokinetics of 5-ALA/SFC in Cancer Patients with Solid Tumors with Chemotherapy Induced Anemia.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
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