XM01-22

XM01-22 was a multinational, multicentre, randomised, double-blind, placebo-controlled phase 3 trial of epoetin theta in anaemic adults with solid tumours or non-myeloid haematological malignancies receiving nonplatinum chemotherapy. Patients were randomised to subcutaneous epoetin theta starting at 20,000 IU once weekly or matching placebo for 12 weeks. The primary endpoint was complete haemoglobin response, defined as a haemoglobin increase of at least 2 g/dL without a transfusion in the previous four weeks.

In the Archives of Drug Information 2011 report, 72.6 percent of patients on epoetin theta and 25.3 percent on placebo had a complete response (P less than 0.0001). Fewer patients on epoetin theta received transfusions after randomisation (13.7 percent versus 25.3 percent, P = 0.0277). Most responders reached their response at the 20,000 IU starting dose. Overall adverse-event frequencies were similar; hypertension was the only adverse event more frequent with epoetin theta (8.4 percent versus 1.1 percent).

The ISRCTN08063129 record carries the protocol serial number XM01-22, names BioGeneriX AG as sponsor and gives an overall end date of 11 May 2007. The Eporatio product information describes this 186-patient nonplatinum study as the first of the two cancer chemotherapy trials behind the anaemia indication. The programme treats chemotherapy-induced anaemia across mixed tumour types rather than a single corpus cancer, so the record carries no cancer ids.