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

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.