Efficacy and safety of XM01 compared to placebo in patients with solid tumours or non-myeloid haematological tumours receiving non-platinum chemotherapy

INTERVENTION: Participants will be randomly allocated to the following two arms: 1. XM01: starting dose subcutaneously 20000 IU once weekly, adjustment up to 40000 and to a maximum of 60000 IU once weekly, or 2. Placebo A follow up phase of 5 years has been foreseen for each treatment arm; the follow up is still ongoing. CONDITION: Solid tumours, non‐myeloid haematological tumours ; Cancer ; Non‐myeloid haematological tumours PRIMARY OUTCOME: Number of patients with a complete haemoglobin response which is defined as the increase in haemoglobin of greater than or equal to 2 g/dL from baseline without the benefit of a transfusion within the previous four weeks. Haematology parameters were measured weekly throughout the 12 week treatment phase; transfusions were documented weekly. SECONDARY OUTCOME: 1. Number of patients having a partial haemoglobin response (defined as increase of ; greater than or equal to 1 g/dL from baseline and no need for transfusion in within the last four weeks); 2. Number of patients having a complete haemoglobin response with the initial dose (weekly starting dose for XM01: 20000IU) and no need for transfusions within the last 4 weeks; 3. Number of patients having a partial haemoglobin response with the initial dose and no need for transfusions within the last 4 weeks; 4. Number of patients receiving transfusions; 5. Number of blood units transfused; 6. Time course of haemoglobin, haematocrit and reticulocytes. Haematology parameters were measured weekly throughout the 12 week treatment phase; transfusions were documented weekly.; 7. Quality of Life assessed by Functional Assessment of Cancer Therapy ‐ Anaemia (Fact‐An) (includes FACT‐G [General] and FACT‐F [Fatigue]). Measurement at baseline, after 6 weeks and at the end of study (12 weeks).; 8. Dose of XM01 at the time of complete/partial haemoglobin response. The weekly dose was documented at the time when the patient achieved a partial or complete response. INCLUSION CRITERIA: 1. Signed and dated written informed consent 2. Adult (aged greater than or equal to 18 years) patients of any ethnic origin 3. Male or female; if female, the patient must meet one of the following criteria: 3.1. Post‐menopausal woman 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 will have to use a double contraception consisting of hormonal treatment (birth control pill, injection or implant, intra‐uterine device [IUD]) plus condom or diaphragm. In women with childbearing potential a pregnancy test (human chorionic gonadotropin [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 non‐platinum chemotherapeutic treatment defi