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NCT02709512 · ClinicalTrials.gov registry record · Phase 2
Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin
A Phase 2 study, sponsored by Polaris Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 249
- Enrollment target
NCT02709512: Completed Phase 2 study, sponsored by Polaris Group.
NCT02709512 is a Phase 2 study that has completed, run by Polaris Group. The registered enrollment target is 249 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02709512, a Phase 2 study, has completed, sponsored by Polaris Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 249 participants
- Enrollment target
Study Summary
This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die.
Primary Outcome
Objective Response Rate is calculated as the proportion of subjects whose best tumor response from all post-baseline tumor assessments is complete response (CR) or partial response (PR). The best tumor response is the best response recorded from the start of the treatment until the end of treatment taking into account any requirement for confirmation. To test Objective Response Rate significance, a Relative Risk Ratio (ADI-PEG 20 / Placebo) was calculated as the common relative risk of having a
Interventions
- DRUG ADI-PEG 20 plus Pem Platinum
- OTHER Placebo plus Pem Platinum
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 249 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2022-08-15 |
| Phase | Phase 2 |
What the finished NCT02709512 record still lists
NCT02709512 is an interventional study that assigns participants to a tested intervention. The registered 249 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% higher).
The record links to 0 conditions, and to 2 interventions - of which ADI-PEG 20 plus Pem Platinum is the first listed.
NCT02709512 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02709512 about?
NCT02709512 is a clinical study titled "Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin". This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-P...
What is the current status of trial NCT02709512?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 249 participants. The study started on 2017-08-01. Estimated completion is 2022-08-15.
What interventions are being tested in trial NCT02709512?
The interventions under investigation include: ADI-PEG 20 plus Pem Platinum (DRUG), Placebo plus Pem Platinum (OTHER).
Who is sponsoring clinical trial NCT02709512?
This trial is sponsored by Polaris Group, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02709512's enrollment target sits among peer trials
249 233rd of 2000 higher than 1,767 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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