Efficacy and safety of XM01 compared to placebo and Epoetin beta in patients with solid tumours receiving platinum-containing chemotherapy

Completed

Conditions: Solid tumours
chemotherapy-associated anaemia
Cancer
Malignant neoplasm without specification of site

Registration Number: ISRCTN09530309

Lead Sponsor: BioGeneriX AG (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 223

Inclusion Criteria

1. Signed and dated written informed consent
2. Adult (age=18 years) patients of any ethnic origin
3. Male or female; if female, the patient must meet one of the following criteria:
3.1. postmenopausal for at least one year
3.2. surgical sterilisation or hysterectomy at least 3 months before the start of the study
3.3. absolute sexual abstinence throughout the participation in the study
3.4. women with childbearing potential must use double contraception consisting of hormonal treatment (birth control pill, injection or implant, IUD) plus condom or diaphragm. In women with childbearing potential a pregnancy test (HCG in urine) should be performed in the trial centre at inclusion and every 4 weeks during the treatment period and 4 weeks after the last administration of study medication.
4. Anaemia caused by platinum-based chemotherapeutic treatment defined by a documented haemoglobin concentration of =11g/dL after the last chemotherapy prior to inclusion
5. Histologically or cytologically proven diagnosis of a solid tumour
6. At least one previous platinum-based chemotherapy cycle as treatment of the current malignancy during the last 4 weeks
7. At least two additional platinum-based chemotherapy cycles or two months of platinum-based chemotherapy planned
8. Eastern Co-operative Oncology Group (ECOG) performance status 0, 1, 2 or 3
9. The patient must be able to understand and follow instructions and must be able to participate in the study for the entire period

Exclusion Criteria

1. Pregnancy or breast feeding
2. Any other primary haematologic disorder that would cause anaemia (e.g. sickle cell anaemia)
3. Anaemia of unknown origin
4. Acute or chronic bleeding
5. Any erythropoietin given during the last 4 weeks or ongoing treatment with other erythropoietins
6. Patients who have been treated with Epoetins with a longer half life time (e.g. novel erythropoiesis stimulating protein [NESP], continuous erythropoietin receptor activator [CERA]) within the last 6 months
7. Known presence of antibodies to Epoetin
8. More than two red blood cell transfusions within 4 weeks before inclusion or any red blood cell transfusions within the last 2 weeks
9. Malignancy of the head or neck
10. Life expectancy less than 3 months
11. Candidate for bone marrow or stem cell transplantation
12. Chemotherapy during the last 7 days before study start
13. Radiotherapy or surgery during the last 14 days before inclusion or planned during the conduct of the study
14. Clinically significant concomitant diseases or condition unrelated to the underlying malignancy or chemotherapy
15. Systemic infection or inflammatory disease
16. Known hypersensitivity (drug intolerance or allergy) to erythropoietin, mammalian cell products or excipients of the formulation
17. History of myocardial infarction, cerebrovascular incident, percutaneous transluminal coronary angioplasty or coronary artery bypass graft within the six months prior to enrolment
18. Uncontrolled severe hypertension or hypertension defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg
19. Congestive heart failure according to New York Heart Association (NYHA) class III or IV
20. Thrombocytosis or thrombocytopenia (platelet count <50 x 109/L or >550 x 109/L)
21. Iron deficiency (Serum ferritin =100 µg/L or TSAT = 20%), defined as follows: No serum ferritin > 100µg/L and TSAT > 20% within the last five weeks before randomisation (For clarification: A patient showing for serum ferritin and for Transferrin Saturation [TSAT] at least one value above these limits during the last five weeks before randomisation can be randomised)
22. Known untreated vitamin B12 or folic acid deficiency, defined by the respective laboratory value at baseline plus clinical symptoms of the deficiency
23. Known positive test for human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
24. Epilepsia, severe endogenous depression or schizophrenia
25. Known impairment of hepatic function
26. Known impairment of renal function
27. History or suspicion of unreliability, poor co-operation or non-compliance with medical treatment
28. History of, or known current problems with drug or alcohol abuse
29. Any other condition that, in the investigator?s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study
30. Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints
31. Participation in a study with investigational drugs within 30 days prior to enrolment or during this study
32. Prior inclusion in the same study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients with a complete haemoglobin response defined as the increase in haemoglobin of = 2 g/dL from baseline without the benefit of a transfusion within the previous four weeks.<br>Haemaematology parameters were measured weekly throughout the 12 week treatment phase; transfusions were documented weekly

Secondary Outcome Measures