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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02454842




Registration number
NCT02454842
Ethics application status
Date submitted
4/05/2015
Date registered
27/05/2015
Date last updated
12/01/2023

Titles & IDs
Public title
Study for Treatment With TH-4000 (Tarloxotinib) in Epidermal Growth Factor Receptor (EGFR) Mutant, T790M-negative Non-small Cell Lung Cancer (NSCLC) Patients
Scientific title
A Phase 2 Study of TH-4000 (Tarloxotinib) in Patients With EGFR-Mutant, T790M-Negative, Advanced Non-Small Cell Lung Cancer Progressing on an EGFR Tyrosine Kinase Inhibitor
Secondary ID [1] 0 0
TH-CR-601
Universal Trial Number (UTN)
Trial acronym
TH-4000
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
NSCLC 0 0
Non-squamous NSCLC 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TH-4000 (Tarloxotinib)

Experimental: TH-4000 (Tarloxotinib) - 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


Treatment: Drugs: TH-4000 (Tarloxotinib)
TH-4000 (Tarloxotinib) is a hypoxia-activated prodrug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with response rate as evaluated by RECIST criteria
Timepoint [1] 0 0
Approximately 12 months
Secondary outcome [1] 0 0
Incidence of adverse events (AEs)
Timepoint [1] 0 0
Up to 30 days after last dose
Secondary outcome [2] 0 0
Type of adverse events (AEs)
Timepoint [2] 0 0
Up to 30 days after last dose
Secondary outcome [3] 0 0
Severity of adverse events (AEs)
Timepoint [3] 0 0
Up to 30 days after last dose
Secondary outcome [4] 0 0
Duration of response (DOR) calculated for all patients achieving an objective response
Timepoint [4] 0 0
Approximately 12 months
Secondary outcome [5] 0 0
Progression-free survival (PFS)
Timepoint [5] 0 0
Approximately 12 months
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
Approximately 12 months
Secondary outcome [7] 0 0
Time to peak plasma concentration (Tmax)
Timepoint [7] 0 0
Cycle 1 Day 1 predose and up to 24 hours post dose
Secondary outcome [8] 0 0
Maximum plasma concentration (Cmax)
Timepoint [8] 0 0
Cycle 1 Day 1 predose and up to 24 hours post dose
Secondary outcome [9] 0 0
Area under concentration-time curve (AUC)
Timepoint [9] 0 0
Cycle 1 Day 1 predose and up to 24 hours post dose
Secondary outcome [10] 0 0
QTc Interval
Timepoint [10] 0 0
Screening, Cycle 1 Day 1, 8, 15 & 22, Day 1 of subsequent cycles

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2017
Sample size
Target
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCullum - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Rain Oncology Inc
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02454842
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Liu
Address 0 0
Georgetown University Hospital Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02454842