Study #2019-1048
A Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics,and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects with Advanced or Metastatic Malignancies Harboring ALK, ROS1, or NTRK1-3 Alterations
MD Anderson Study Status
Enrolling
Treatment Agent
Oral repotrectinib (TPX-0005)
Description
Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D). Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Locally Advanced Solid Tumors, Metastatic Solid Tumors, Lymphoma, Primary CNS Tumors
Study phase:
Physician name:
Jonathan Gill
Department:
Pediatrics
For general questions about clinical trials:
1-877-632-6789
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