MedTrace Logo

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

NCT01266018 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-10-25

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

ADI-PEG 20 (Arginine deiminase pegylated)

ADI-PEG 20 was administered intramuscularly (IM) at a fixed dose of 320 IU/m\^2 (36.8 mg/m\^2) once weekly for 4 weeks followed by a 1-week follow-up (1 cycle)

Sponsors & Collaborators

  • Memorial Sloan Kettering Cancer Center

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • St. Bartholomew's Hospital

    collaborator OTHER

  • Krankenhaus Nordwest

    collaborator OTHER

  • Saint-Luc University Hospital

    collaborator UNKNOWN

  • National Taiwan University Hospital

    collaborator OTHER

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • Austin Health

    collaborator OTHER_GOV

  • Polaris Group

    collaborator INDUSTRY

  • Ludwig Institute for Cancer Research

    lead OTHER

Principal Investigators

  • Lee M Krug, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States
  • Belgium
  • Germany
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01266018 on ClinicalTrials.gov