Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer
Status:
Terminated
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborators:
Austin Health Chang Gung Memorial Hospital Duke University Krakenhaus Nordwest Krankenhaus Nordwest Memorial Sloan Kettering Cancer Center National Cheng-Kung University Hospital National ChengKung University Hospital National Taiwan University Hospital Polaris Group Saint-Luc University Hospital St. Bartholomew's Hospital St. Luc Hospital