Study for Treatment With TH-4000 (Tarloxotinib) in Epidermal Growth Factor Receptor (EGFR) Mutant, T790M-negative Non-small Cell Lung Cancer (NSCLC) Patients
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.
Checked against the public recordLast updated Jan 12, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Rain Oncology Inc
- Interventions being studied
- Drug: TH-4000 (Tarloxotinib)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Southern California-NorrisLos Angeles, California
- St. Joseph Heritage HealthcareSanta Rosa, California
- University of Colorado Cancer CenterAurora, Colorado
- Georgetown University Medical CenterWashington D.C., District of Columbia
- Walter Reed National Military Medical CenterBethesda, Maryland
- University of North Carolina Lineberger Cancer CenterChapel Hill, North Carolina
- University of Pennsylvania-Abramson Cancer CenterPhiladelphia, Pennsylvania
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
- Vanderbilt-Ingram Cancer Center (VICC)Nashville, Tennessee
- UT Southwestern Medical CenterDallas, Texas
- Swedish Cancer InstituteSeattle, Washington
- Peter MacCullumMelbourne, Victoria
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 12, 2023. Always confirm current availability with the study team.