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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.

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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

FieldValue
Enrollment Target 140 participants
Start Date 2014-11
Est. Completion 2020-02
Phase Phase 1

Sponsor

Polaris Group

13 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.