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NCT02047344 · ClinicalTrials.gov registry record · Phase 2

Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC

A Phase 2 study of Non-small Cell Lung Cancer Stage IV, sponsored by Golden Biotechnology Corporation.

Completed
Registry status
Phase 2
Development phase
31
Enrollment target
10
Study locations

NCT02047344 is a Phase 2 study of Non-small Cell Lung Cancer Stage IV that has completed, run by Golden Biotechnology Corporation. The registered enrollment target is 31 participants, below the 111-participant average among 4 other Non-small Cell Lung Cancer Stage IV trials with a reported enrollment target (72% lower). The trial reports 10 study locations across 7 states.

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The verdict

NCT02047344, a Phase 2 study of Non-small Cell Lung Cancer Stage IV, has completed, sponsored by Golden Biotechnology Corporation.

COMPLETED
Registry status
Phase 2
Development phase
31 participants
Enrollment target
10
Study locations

Study Summary

This is a single arm, open label, Phase II study in KRAS-positive and KRAS-negative patients with stage IV (including pleural effusion) non squamous NSCLC who have failed two lines of anti-cancer therapy. A maximum of 60 evaluable patients with NSCLC will receive antroquinonol, of which 30 patients will be KRAS-positive and 30 patients KRAS-negative. An evaluable patient will have received at least one dose of antroquinonol and have a valid baseline tumor assessment. Enrollment will continue until the target number of evaluable patients has been enrolled.

Conditions Studied

Non-small Cell Lung Cancer Stage IV

Interventions

  • DRUG Antroquinonol

Study Locations (10)

Other

  • Chang Gung Memorial Hospital-Kaohsiung medical center - Kaohsiung City
  • National Cheng Kung University Hospitail - Tainan
  • Tri Service General Hospital - Taipei

Maryland

  • John Hopkins University - Baltimore
  • Peninsula Regional Med Center - Salisbury

Arizona

  • Arizona Clinical Research Center - Tucson

California

  • UCSF - San Francisco

Illinois

  • Rush University Medical Center - Chicago

Michigan

  • Henry Ford health system - Detroit

Pennsylvania

  • Guthrie Clinic, Ltd - Sayre

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2013-10
Est. Completion 2018-12-07
Phase Phase 2

Sponsor

Golden Biotechnology Corporation

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02047344

The ClinicalTrials.gov registry entry for NCT02047344 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 111-participant average among 4 other Non-small Cell Lung Cancer Stage IV trials with a reported enrollment target (72% lower). The listed sponsor is Golden Biotechnology Corporation, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-small Cell Lung Cancer Stage IV appearing as the primary indexed condition, and to 1 intervention - of which Antroquinonol is the first listed.

NCT02047344 reports 10 study locations spanning 7 distinct geographic areas - top geographies include Other, Maryland, Arizona.

Frequently Asked Questions

What is clinical trial NCT02047344 about?

NCT02047344 is a clinical study titled "Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC". This is a single arm, open label, Phase II study in KRAS-positive and KRAS-negative patients with stage IV (including pleural effusion) non squamous NSCLC who have failed two lines of anti-cancer therapy. A maximum of 60 evaluable patients with NSCLC will receive antroquinonol, of which 30 patients ...

What is the current status of trial NCT02047344?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2013-10. Estimated completion is 2018-12-07.

What conditions does trial NCT02047344 study?

This clinical trial studies the following conditions: Non-small Cell Lung Cancer Stage IV.

What interventions are being tested in trial NCT02047344?

The interventions under investigation include: Antroquinonol (DRUG).

Who is sponsoring clinical trial NCT02047344?

This trial is sponsored by Golden Biotechnology Corporation, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02047344 being conducted?

This trial has 10 study locations across Arizona, California, Illinois, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.