Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations. (STARTRK-1)

This is an interventional treatment trial for Locally Advanced Solid Tumors Read More

Key Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors that have a NTRK1, NTRK2, NTRK3, ROS1, or ALK molecular alteration.
• Measurable disease according to RECIST version 1.1.
• Prior cancer therapy is allowed, including crizotinib, ceritinib, and investigational drugs.
• Prior radiotherapy is allowed
• Patients with controlled asymptomatic central nervous system involvement are allowed.
• Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
• Adult patients age 18 years or older.
• Life expectancy of at least 3 months.

Key Exclusion Criteria:

• Current participation in another therapeutic clinical trial.
• Prior treatment with entrectinib.
• History of prolonged QTc interval (e.g., repeated demonstration of a QTc interval > 450 milliseconds).
• History of additional risk factors for torsade de pointes (e.g., family history of long QT syndrome).
• Known active infections (bacterial, fungal, viral including HIV positivity).
• Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.
• Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis.
• Peripheral neuropathy ≥ Grade 2.