Study for Treatment With TH-4000 (Tarloxotinib) in Epider... | NCT02454842

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of efficacy

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 31, 2017Actual

First Submitted Date

May 4, 2015

First Submission Date that Met QC Criteria

May 21, 2015

First Posted Date

May 27, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Dec 7, 2022

Certification/Extension First Submitted that Passed QC Review

Dec 7, 2022

Certification/Extension First Posted Date

Dec 12, 2022Actual

Last Update Submitted Date

Jan 9, 2023

Last Update Posted Date

Jan 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

A single arm open label multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 will be assessed in patients with EGFR mutant, T790M negative advanced NSCLC. Patients must have demonstrated progression during EGFR TKI therapy.

Hypoxia PET scans will be obtained in select centers to analyze potential predictors of tumor response.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
TH-4000 (Tarloxotinib)	Drug	TH-4000 (Tarloxotinib) is a hypoxia-activated prodrug	TH-4000 (Tarloxotinib)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with response rate as evaluated by RECIST criteria		Approximately 12 months

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Measure	Description	Time Frame
Hypoxic volume as measured by Positron Emission Tomography (PET) hypoxia imaging		Baseline

Eligibility Module

Eligibility Criteria

Key Eligibility Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Confirmed recurrent Stage IV NSCLC which progressed while on treatment with EGFR TKI
Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Documented evidence of an EGFR mutation known to be associated with an EGFR TKI sensitivity
No T790M mutation or small cell transformation including an assessment from tumor biopsy obtained while on or subsequent to the most recent EGFR TKI therapy
Acceptable laboratory results as indicated by protocol
Acceptable cardiac function as indicated by protocol

Key Exclusion Criteria:

Receiving medication that prolongs QT interval, with a risk of causing Torsades de Pointes (TdP) unless ECG meets inclusion criteria while on a stable dose of the medication
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Stephen Liu	Georgetown University Hospital Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Southern California-Norris		Los Angeles	California	90033	United States
St. Joseph Heritage Healthcare

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D000860	Hypoxia
D002294	Carcinoma, Squamous Cell

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D018307	Neoplasms, Squamous Cell