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NCT02102022 · ClinicalTrials.gov registry record · Phase 1
Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma
A Phase 1 study, sponsored by Polaris Group.
- Terminated
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
NCT02102022: Clinical Trial Phase 1 study, sponsored by Polaris Group.
NCT02102022 is a Phase 1 study that was terminated before completion, run by Polaris Group. The registered enrollment target is 140 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (133% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02102022, a Phase 1 study, was terminated before completion, sponsored by Polaris Group.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
Study Summary
Phase 1: Assessment of safety and tolerability of ADI-PEG 20 in combination with folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX) in advanced GI malignancies. Phase 2: Assessment of the objective response rate (ORR), measured by RECIST 1.1 criteria as assessed by blinded independent central review (BICR).
Primary Outcome
The percent of subjects who exhibit each level of tumor response, measured by RECIST 1.1 criteria as assessed by blinded independent central review.
Interventions
- DRUG ADI-PEG 20 plus modified FOLFOX6
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2014-11 |
| Est. Completion | 2020-02 |
| Phase | Phase 1 |
Why NCT02102022 stopped before completion
NCT02102022 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (133% higher).
The record links to 0 conditions, and to 1 intervention - of which ADI-PEG 20 plus modified FOLFOX6 is the first listed.
NCT02102022 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02102022 about?
NCT02102022 is a clinical study titled "Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma". Phase 1: Assessment of safety and tolerability of ADI-PEG 20 in combination with folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX) in advanced GI malignancies. Phase 2: Assessment of the objective response rate (ORR), measured by RECIST 1.1 criteria as assessed by blinded independent...
What is the current status of trial NCT02102022?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2014-11. Estimated completion is 2020-02.
What interventions are being tested in trial NCT02102022?
The interventions under investigation include: ADI-PEG 20 plus modified FOLFOX6 (DRUG).
Who is sponsoring clinical trial NCT02102022?
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 NCT02102022's enrollment target sits among peer trials
140 402nd of 2000 higher than 1,583 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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