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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 is a Phase 1 study that was terminated before completion, run by Polaris Group. The registered enrollment target is 140 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02102022
The ClinicalTrials.gov registry entry for NCT02102022 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Polaris Group, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ADI-PEG 20 plus modified FOLFOX6 is the first listed.
NCT02102022 reports 0 study locations.
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.
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