A multicenter, randomized, open-label dose finding study of RO0503821 in anemic patients with stage IIIB or IV non-small cell lung cancer receiving first line myelosuppressive chemotherapy
- Conditions
- Anemic patients undergoing chemotherapy
- Registration Number
- EUCTR2005-005405-37-EE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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
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
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.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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To select an optimal starting dose of RO0503821 to be used for the phase III trials<br>To confirm the dose modification guidelines of RO0503821 to be used for the phase III trials<br>;Secondary Objective: To assess the safety profile of RO0503821<br>To study the pharmacokinetics of RO0503821<br>;Primary end point(s): Average Hb change from baseline during weeks 5 – 13 (days 29 – 85 or last assessment)
- Secondary Outcome Measures
Name Time Method