A multicenter, randomized, open-label dose finding study of RO0503821 in anemic patients with stage IIIB or IV nonsmall cell lung cancer receiving first line myelosuppressive chemotherapy - ND

• Conditions: Anemia in cancer patients receiving chemotherapy; MedDRA version: 6.1Level: PTClassification code 10061873

• Registration Number: EUCTR2005-005405-37-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-23
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age 8805;18 years 2. Cytologically or histologically confirmed diagnosis of stage IIIB or IV NSCLC receiving first line myelosuppressive chemotherapy without plannedthoracic radiotherapy 3. Hemoglobin 8804;11 g/dL 110 g/L at screening visit 4. Myelosuppressive chemotherapy scheduled for at least 9 weeks 5. Life expectancy 8805;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

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 during the study 3. Prior diagnosis of myeloid malignancy 4. Known primary or metastatic malignancy of the central nervous system 5. Uncontrolled hypertension 6. Iron deficiency defined as both transferrin saturation 20 and serum ferritin 100 ng/mL 224 pmol/L 7. Grade 3/4 thrombocytopenia platelet count 50 x 109/L 8. Known uncorrected vitamin B12 or folic acid deficiency 9. Prior diagnosis of primary red cell disorders which cause anemia i.e., hemoglobinopathy, PRCA 10. Significant hemolysis requiring medical intervention 11. 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 12. Acute infection requiring parenteral antibiotic therapy 13. History of seizures within the previous 6 months 14. Pregnancy or breastfeeding 15. Women of child bearing potential without effective contraception 16. Any ESA administered during the period beginning 28 days preceding the first dose of study medication or planned during the study period 17. Any investigational drug administered during the period beginning 28 days preceding the first dose of study medication 18. Prior treatment with RO0503821 19. Known resistance to other ESAs 20. Known hypersensitivity to darbepoetin alfa, recombinant human erythropoietin, polyethylene glycol or to any constituent of the study or reference drug formulations

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified