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Antroquinonol

Phase 2

Non-small Cell Lung Cancer Stage IV | Small molecule | Oncology |Icon Plc|Last Updated: Dec 26, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

Antroquinonol · 1 trial · 1 indication

Phase 2 1
NCT02047344Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLCNon-small Cell Lung Cancer Stage IV
COMPLETED31 Analytics
PHASE2COMPLETED
Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC
Non-small Cell Lung Cancer Stage IVUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression Free Survival Rate
12 weeks

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.

Secondary Endpoints

Cmax
8 hours
Disease Control Rate (DCR)
12 weeks
T½: the Time Required for a Quantity to Reduce to Half Its Initial Value
8 hours
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Antroquinonol (Hocena)EXPERIMENTALpatients 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.

Interventions

NameTypeDescription
AntroquinonolDRUGpatients 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Cytologically or histologically confirmed non squamous NSCLC Stage IV (including pleural effusion). * Radiologically confirmed disease progression following two previous lines of anti-cancer therapy, one of which should be a platinum based regimen, OR the patient has refused t...

Countries:United StatesTaiwan
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Frequently asked questions about Antroquinonol

What is Antroquinonol used for?

Antroquinonol is an investigational small molecule being studied for the treatment of Stage IV Non-small Cell Lung Cancer (NSCLC). It is currently in clinical development and has not been approved by regulatory authorities. A Phase 2 trial has been completed to evaluate its efficacy, safety, and pharmacokinetics in patients with this condition.

Who is developing Antroquinonol?

Antroquinonol is being developed by Icon Plc, a company listed on the NASDAQ under the ticker symbol ICLR. The company is conducting clinical research on this investigational drug for the treatment of Stage IV Non-small Cell Lung Cancer.

What phase is Antroquinonol in?

Antroquinonol is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational. It has not received FDA approval and is still undergoing clinical evaluation for its safety and efficacy in treating Stage IV Non-small Cell Lung Cancer.

What clinical trials is Antroquinonol in?

Antroquinonol has one completed clinical trial registered under NCT02047344, titled 'Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC.' This Phase 2 study enrolled 31 participants with Stage IV Non-small Cell Lung Cancer and was conducted in the United States and Taiwan.

Is Antroquinonol the same as any other drug?

Antroquinonol is the primary name for this investigational drug. No alternative names have been established in the available clinical trial information. It is being studied under the identifier NCT02047344 for its potential use in treating Stage IV Non-small Cell Lung Cancer.