Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations.
