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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: Completed Phase 2 study of Non-small Cell Lung Cancer Stage IV, sponsored by Golden Biotechnology Corporation.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Tumor response will be assessed at 6 week intervals during the first treatment cycle using the RECIST criteria, version 1.1. Each patient will be assigned one of the following categories: 1) complete response (CR), 2) partial response (PR), 3) stable disease (SD), or 4) progressive disease (PD). Patients who died from any cause or discontinued the study for any reason without a post screening or Week 12 tumor assessment will be considered as failing to respond to treatment.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-10 |
| Est. Completion | 2018-12-07 |
| Phase | Phase 2 |
What the finished NCT02047344 record still lists
NCT02047344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 111-participant average among 4 other Non-small Cell Lung Cancer Stage IV trials with a reported enrollment target (72% lower).
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 lists 10 locations in 7 states (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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