Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC

NCT02047344 | Completed Phase 2 Results DMC

• 1 other identifier: GHNSCLC-2 001
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 10

Brief 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

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival Rate

  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.

  12 weeks

Secondary Outcomes (3)

• 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

Other Outcomes (2)

• Objective Response Rate (ORR)

  12 weeks

• Overall Survival

  up to week 48

Study Arms (1)

Antroquinonol (Hocena)

EXPERIMENTAL

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.

Drug: Antroquinonol

Interventions

Antroquinonol DRUG

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.

Also known as: Hocena

Antroquinonol (Hocena)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 treatment with approved treatment modalities
• At least one radiologically measurable target lesion per RECIST version 1.1
• Fresh or archival biopsy tissue available to determine tumor mutation status
• Written informed consent that is consistent with International Conference on Harmonisation Tripartite Guideline on Good Clinical Practice guidelines
• Patient or legally acceptable representative has granted written informed consent before any study specific procedures (including special Screening tests) are performed
• Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2
• Hemoglobin ≥ 9.0 g/dL; platelets ≥ 100 x 109/L; absolute neutrophil count ≥ 1.5 x 109/L without the use of hematopoietic growth factors
• Bilirubin and creatinine less than 2 × upper limit of normal (ULN) for the institution
• Albumin ≥ 2.5 mg/dL
• Aspartate aminotransferase and alanine aminotransferase less than 5 × ULN for the institution
• Prothrombin time less than 1.5 × ULN for the institution
• Potassium, magnesium and phosphorus within the normal range for the institution (supplementation is permissible)
• Recovery to Grade 1 or baseline of any toxicities due to prior treatments, excluding alopecia

You may not qualify if:

• Chemo-, hormone- or immunotherapy, within 4 weeks or within less than four half lives of the date of first administration of study drug and/or persistence of toxicities of prior anti-cancer therapies which are deemed to be clinically relevant
• Radiotherapy within the past 2 weeks prior to date of first administration of study drug
• Previous treatment with an histone deacetylase inhibitor or an epidermal growth factor receptor inhibitor within at least 4 weeks of the date of first administration of study drug
• Treatment with any drug(s) known to be an inhibitor or inducer of cytochrome P450 (CYP)2C19, CYP3A4, CYP2C8, and CYP2E1, within 14 days of the date of first administration of study drug
• Brain metastases, which are symptomatic; patients with treated, brain metastases are eligible with stable brain disease for at least 4 weeks without the requirement for steroids or anti epileptic therapy
• Inability to swallow oral medications or a recent acute gastrointestinal disorder with diarrhea e.g., Cohn's disease, malabsorption, or Common Terminology Criteria for Adverse Event (CTCAE) Grade \> 2 diarrhea of any etiology at baseline
• Other malignancies diagnosed within the past five years (other than curatively treated cervical cancer in situ), non melanoma skin cancer, superficial bladder tumors Ta (non invasive tumor) and TIS (carcinoma in situ)
• Patients with any serious active infection (i.e., requiring an intravenous antibiotic, antifungal, or antiviral agent)
• Patients with known human immunodeficiency virus, active hepatitis B or active hepatitis C
• Patients who have any other life threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the study drug
• Known or suspected substance abuse or alcohol abuse
• Pregnancy or breast feeding
• History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association functional classification of three

Sponsors & Collaborators

• Golden Biotechnology Corporation: lead
• ICON Clinical Research: collaborator

Study Sites (10)

Arizona Clinical Research Center

Tucson, Arizona, 85715, United States

Location

UCSF

San Francisco, California, 94115, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

John Hopkins University

Baltimore, Maryland, 21287, United States

Location

Peninsula Regional Med Center

Salisbury, Maryland, 21801, United States

Location

Henry Ford health system

Detroit, Michigan, 48202, United States

Location

Guthrie Clinic, Ltd

Sayre, Pennsylvania, 18840, United States

Location

Chang Gung Memorial Hospital-Kaohsiung medical center

Kaohsiung City, 88301, Taiwan

Location

National Cheng Kung University Hospitail

Tainan, 704, Taiwan

Location

Tri Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

antroquinonol

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Howard Cheng
• Organization: Golden Biotechnology Corp.

howard@goldenbiotech.com

+886-2-28086006

Study Officials

• Howard Cheng, Ph.D.

  Golden Biotechnology Corp.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2014
• First Posted: January 28, 2014
• Study Start: October 1, 2013
• Primary Completion: December 7, 2018
• Study Completion: December 7, 2018
• Last Updated: December 26, 2019
• Results First Posted: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); TW (3)