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NCT01266018 · ClinicalTrials.gov registry record · Phase 2
Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer
A Phase 2 study, sponsored by Ludwig Institute for Cancer Research.
- Terminated
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT01266018 is a Phase 2 study that was terminated before completion, run by Ludwig Institute for Cancer Research. The registered enrollment target is 22 participants.
The verdict
NCT01266018, a Phase 2 study, was terminated before completion, sponsored by Ludwig Institute for Cancer Research.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study 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.
Interventions
- DRUG ADI-PEG 20 (Arginine deiminase pegylated)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2011-01 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01266018
The ClinicalTrials.gov registry entry for NCT01266018 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ludwig Institute for Cancer Research, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ADI-PEG 20 (Arginine deiminase pegylated) is the first listed.
NCT01266018 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01266018 about?
NCT01266018 is a clinical study titled "Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer". 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 object...
What is the current status of trial NCT01266018?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2011-01. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01266018?
The interventions under investigation include: ADI-PEG 20 (Arginine deiminase pegylated) (DRUG).
Who is sponsoring clinical trial NCT01266018?
This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.
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