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Clinical trialNCT01266018TerminatedPhase 2Interventional

Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer

SponsorLudwig Institute for Cancer ResearchEnrollment22Small Cell Lung Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Belgium
  • University Clinic Saint-Luc

    Brussels, Belgium

Germany
  • Krankenhaus Nordwest

    Frankfurt, Germany

Taiwan
  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Chang Gung Memorial Hospital - Linkou Branch

    Taoyuan, Taiwan

United Kingdom
  • St. Bartholomew'S Hospital

    West Smithfield, London, United Kingdom

United States
  • Memorial Sloan-Kettering Cancer Center

    New York, New York, United States

  • Duke University Medical Center

    Durham, North Carolina, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ADI-PEG 20
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jan 2011
Primary completion
31 Jan 2014
Completion
31 Jan 2014
Last update posted
25 Oct 2022
Registered enrollment
22
Registry id
NCT01266018
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.