Full TitleTPX-0005-01: A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1) (Version 2.0 Date: 03-NOV-2016)
TPX-0005 is an investigational drug that inhibits the activity of abnormal forms of certain proteins involved in cancer growth, such as ALK, ROS1, NTRK1, NTRK2, and NTRK3. In this study, researchers are evaluating the safety and effectiveness of TPX-0005 in patients with inoperable or metastatic solid tumors containing altered versions of the genes that produce these proteins. TPX-0005 is taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have an inoperable or metastatic solid tumor that contains an altered form of at least one of these genes: ALK (such as non-small cell lung cancer), ROS1, NTRK1, NTRK2, or NTRK3.
- At least 2 weeks must pass between the completion of prior therapy and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.