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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: Clinical Trial Phase 2 study, sponsored by Ludwig Institute for Cancer Research.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Tumor responses were evaluated using any appropriate imaging type and were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions \[no evidence of disease\]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable
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 |
Why NCT01266018 stopped before completion
NCT01266018 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which ADI-PEG 20 (Arginine deiminase pegylated) is the first listed.
NCT01266018 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01266018's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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