Anemic patients undergoing chemotherapy
Conditions
Interventions
Product Name: RO0503821
Product Code: RO0503821
Pharmaceutical Form: Solution for injection
INN or Proposed INN: not available
CAS Number: 677324-53-7
Concentration unit: µg/ml microgram(s)/millilitre
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Cytologically or histologically confirmed diagnosis of: stage IIIB or IV NSCLC receiving first line myelosuppressive chemotherapy (without planned concurrent thoracic radiotherapy) 3. Hemoglobin =11 g/dL (110 g/L) at screening visit 4. Myelosuppressive chemotherapy scheduled for at least 9 weeks from first planned dose of study medication 5. Life expectancy =6 months 6. ECOG performance status 0-2 7. 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: 1. Transfusion of red blood cells during the 4 weeks (28 days) prior to the first planned dose of study medication 2. Radiation therapy to >25% of bone marrow containing areas within the 2 weeks (14 days) prior to the first planned dose of study medication or planned thoracic radiotherapy to be administered concurrently during the study 3. Prior diagnosis of myeloid malignancy 4. Known primary or metastatic malignancy of the central nervous system 5. STAGE II HYPERTENSION: stage II hypertension is defined as SBP > 160mmHg or DBP >100mmHg 6. AST/ALT > 5xULN 7. Iron deficiency defined as both transferrin saturation <20% and serum ferritin <100 ng/mL (224 pmol/L) 8. Grade 3/4 thrombocytopenia: platelet count <50 x 109/L 9. Known uncorrected vitamin B12 or folic acid deficiency 10. Prior diagnosis of primary red cell disorders which cause anemia (i.e., hemoglobinopathy, PRCA) 11. Significant hemolysis requiring medical intervention 12. Acute or chronic bleeding requiring therapy within 3 months prior to planned start of study medication (e.g. patients with anemia caused by gastrointestinal bleeding) 13. Acute infection requiring parenteral antibiotic therapy 15. Pregnancy or breastfeeding 16. Women of child bearing potential without effective contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To select an optimal starting dose of RO0503821 to be used for the phase III trials To confirm the dose modification guidelines of RO0503821 to be used for the phase III trials ;Secondary Objective: To assess the safety profile of RO0503821 To study the pharmacokinetics of RO0503821 ;Primary end point(s): Average Hb change from baseline during weeks 5 – 13 (days 29 – 85 or last assessment) | — |
Countries
Austria, Czech Republic, Estonia, Finland, Germany, Greece, Hungary, Italy, Spain
Outcome results
None listed