drugset / Trial / NCT00152477
A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
A 2-part study to examine safety, tolerability and pharmacokinetics (part 1), and anti-tumour effects (part 2), of CDP791 combined with carboplatin and paclitaxel.
Timeline
- Start
- 2005-08-15
- Primary completion
- 2009-06-25
- Completion
- 2009-06-25
Outcome
Missed primary endpoint
registry analysis (superiority test); Carboplatin/Paclitaxel (Randomized Part II SjS) vs Carboplatin/Paclitaxel/CDP791 (Randomized Part II SjS); p =0.384; Difference of response rate 6.4 (95% CI -7.7 to 20.5); NCT00152477 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALACIZUMAB PEGOL | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | ALACIZUMAB PEGOL | Monoclonal antibody | 20 mg/kg | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |