TPX-0131-01: This Phase I/II trial is trying to understand how safe and effective a targeted therapy (TPX-0131) is in people with ALK+ advanced or metastatic Non-Small Cell Lung CancerA Phase 1/2 Study of TPX-0131, A Novel Oral ALK Tyrosine Kinase Inhibitor in Subjects With ALK+ Advanced or Metastatic NSCLC

Exclusion

• Major surgery within four weeks of the start of TPX-0131 treatment.
• Clinically significant cardiovascular disease

• Any of the following cardiac criteria:

  • Mean resting corrected QT interval (QTc) > 470 msec obtained from three ECGs and any factors that increase the risk of QTc prolongation or arrhythmic events
  • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG
• Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).
• Gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.
• Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.
• Subjects with current or anticipated need for drugs that are sensitive CYP2C9 substrates with narrow therapeutic indices.