Study for Treatment With TH-4000 (Tarloxotinib) in Epidermal Growth Factor Receptor (EGFR) Mutant… (NCT02454842) | Clinical Trial Compass
TerminatedPhase 2
Study for Treatment With TH-4000 (Tarloxotinib) in Epidermal Growth Factor Receptor (EGFR) Mutant, T790M-negative Non-small Cell Lung Cancer (NSCLC) Patients
Stopped: Lack of efficacy
United States21 participantsStarted 2015-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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) …
What they're measuring
1
Number of participants with response rate as evaluated by RECIST criteria