NCT02454842

Brief Summary

This phase 2 study is designed to evaluate the safety and activity of TH-4000 a hypoxia-activated prodrug, in patients with EGFR-Mutant, T790M-Negative, Advanced NSCLC.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
2 countries

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

1.6 years

First QC Date

May 4, 2015

Last Update Submit

January 9, 2023

Conditions

Non-small Cell Lung CancerNSCLCNon-squamous NSCLC

Keywords

TH-4000low-oxygen conditionshypoxianon-small cell lung cancerNSCLCsquamous cell carcinomaTarloxotinib

Outcome Measures

Primary Outcomes (1)

  • Number of participants with response rate as evaluated by RECIST criteria

    Approximately 12 months

Secondary Outcomes (10)

  • Incidence of adverse events (AEs)

    Up to 30 days after last dose

  • Type of adverse events (AEs)

    Up to 30 days after last dose

  • Severity of adverse events (AEs)

    Up to 30 days after last dose

  • Duration of response (DOR) calculated for all patients achieving an objective response

    Approximately 12 months

  • Progression-free survival (PFS)

    Approximately 12 months

  • +5 more secondary outcomes

Other Outcomes (1)

  • Hypoxic volume as measured by Positron Emission Tomography (PET) hypoxia imaging

    Baseline

Study Arms (1)

TH-4000 (Tarloxotinib)

EXPERIMENTAL

TH-4000 (Tarloxotinib), 150 mg/m2 will be administered by IV infusion on Days 1, 8, 15, and 22 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity

Drug: TH-4000 (Tarloxotinib)

Interventions

TH-4000 (Tarloxotinib)DRUG

TH-4000 (Tarloxotinib) is a hypoxia-activated prodrug

TH-4000 (Tarloxotinib)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Family history of long corrected QT interval (QTc) syndrome
  • Symptomatic central nervous system (CNS) lesions
  • Radiation therapy within 2 weeks prior to the first dose of study medication
  • Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
  • Concurrent active malignancy requiring systemic treatment
  • Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus \[HIV\]), recent (within 6 months) myocardial infarction or unstable angina, congestive heart failure, poorly-controlled hypertension or diabetes, concurrent active malignancy, or psychiatric condition that may interfere with the patient's ability to follow study procedures
  • Pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of Southern California-Norris

Los Angeles, California, 90033, United States

Location

St. Joseph Heritage Healthcare

Santa Rosa, California, 95403, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

University of North Carolina Lineberger Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

University of Pennsylvania-Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Vanderbilt-Ingram Cancer Center (VICC)

Nashville, Tennessee, 37232, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Peter MacCullum

Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungHypoxiaCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Study Officials

  • Stephen Liu

    Georgetown University Hospital Cancer Center

    PRINCIPAL INVESTIGATOR

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

May 4, 2015

First Posted

May 27, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 31, 2017

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations

AU(1)US(11)