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Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC

NCT02047344 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-12-26

Study results available
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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

  • Non-small Cell Lung Cancer Stage IV

Interventions

DRUG

Antroquinonol

patients will receive one 12 week cycle of antroquinonol 200 mg t.i.d. or until disease progression, unacceptable toxicity, non compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first.

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • Golden Biotechnology Corporation

    lead INDUSTRY

Principal Investigators

  • Howard Cheng, Ph.D. · Golden Biotechnology Corp.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2018-12-07
Completion
2018-12-07

Countries

  • United States
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02047344 on ClinicalTrials.gov