drugset / Trial / NCT01266018
Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer
Phase 2
Terminated
22 enrolled
Ludwig Institute for Cancer Research
Austin Health · collabChang Gung Memorial Hospital · collabDuke University · collabKrankenhaus Nordwest · collabMemorial Sloan Kettering Cancer Center · collabNational Cheng-Kung University Hospital · collabNational Taiwan University Hospital · collabPolaris Group · collabSaint-Luc University Hospital · collabSt. Bartholomew's Hospital · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This was a 2-arm, open-label, phase 2 study of pegylated arginine deiminase (ADI-PEG) 20 in subjects with relapsed sensitive or refractory small cell lung cancer (SCLC). ADI-PEG 20 was administered intramuscularly (IM) at a fixed dose of 320 IU/m\^2 once weekly for a 4-week cycle. The primary objective was to assess clinical efficacy with a primary endpoint of tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after 4 weeks. Secondary objectives were to assess the safety, pharmacodynamics, and immunogenicity of ADI-PEG 20, as well as clinical efficacy with a secondary endpoint of overall survival.
Timeline
- Start
- 2011-01
- Primary completion
- 2014-01
- Completion
- 2014-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegargiminase | Protein / enzyme biologic | 320 iu | Other |