Anaemia in adult patients with solid tumors treated with non-platinum containing chemotherapy MedDRA version: 8.1 Level: PT Classification code 10049105
Conditions
Interventions
Trade Name: NeoRecormon 30.000 IU (prefilled syringe)
Product Name: NeoRecormon 30.000 IU pre-filled syringe
Product Code: Ro 205-3859
Pharmaceutical Form: Solution for injection
INN or Proposed INN:
Sponsors
N.V. Roche S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Adult (= 18 years) patients with solid tumors treated with non-platinum containing chemotherapy, which is scheduled for at least 12 weeks •Haemoglobin 6 months •Written 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Transfusion of red blood cells during the 2 months prior to first planned dose of study medication •Therapy-resistant hypertension (sitting systolic blood pressure = 170 mmHg and diastolic blood pressure = 110 mmHg) •Known clinically relevant acute or chronic bleeding, i.e. requiring therapy within 3 months prior to planned start of study treatment, e.g. patient with anaemia caused by gastrointestinal bleeding •Known vitamin B12 deficiency, e.g. erythrocyte MCV > 105 fL •Known folic acid deficiency, e.g. erythrocyte MCV > 105 fL •Known haemolysis: haptoglobin 450 x 109/L at visit 1 •Epilepsy •Pregnancy or lactation period •Any unregistered drug in the 30 days preceding the first dose of the study medication or during the study •Patients who previously completed or prematurely withdrew from this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective of this study is to evaluate the efficacy of NeoRecormon 30 000 IU once weekly in the treatment of anaemia in adult patients with solid tumors treated with non-platinum containing chemotherapy with emphasis on achieving a rapid haemoglobin increase (> 1 g/dL), i.e. after 4 weeks.;Main Objective: The primary objective of the study is to demonstrate that once-weekly NeoRecormon therapy is safe and well tolerated when administered via a 30 000 IU pre-filled syringe in adult patients with solid tumors treated with non-platinum containing chemotherapy. This will be achieved by monitoring of haematology and blood chemistry, blood pressure, and continuous recording of adverse events. ;Primary end point(s): The primary study variable is defined as the overall incidence of patients reporting adverse events after study medication start. Adverse events will be coded using de MEDdra dictionary. Frequencies and exact 95% confidence intervals will be calculated for the number of patients reporting adverse events, overall and by body system. | — |
Countries
Belgium
Outcome results
None listed