Study for Treatment of Patients With EGFR Mutant, T790M-negative NSCLC

• Status: Terminated
• Trial end date: 2017-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase 2 study is designed to evaluate the safety and activity of TH-4000 (Tarloxotinib), a hypoxia-activated prodrug, in patients with EGFR-Mutant, T790M-Negative, Advanced non-small cell lung cancer (NSCLC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Threshold Pharmaceuticals

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 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