A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
Phase 1/2
75
about 7.6 years
≤25
20 sites in CA, CO, FL +12
What this study is about
This trial is testing a treatment called repotrectinib to see if it's safe and effective for children and young adults with certain types of cancer. The goal is to find the best dose level and determine if this drug can help fight the cancer.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Oral repotrectinib (TPX-0005)
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
repotrectinib
oral (Oral Capsule)
Primary: Overall Response Rate (ORR) (Phase 2)
Secondary: Area under the concentration versus time curve of repotrectinib in plasma (AUC), Central Nervous System Progression-Free Survival (CNS-PFS) (Phase 2), Duration of response (DOR) (Phase 1 and Phase 2), Intracranial objective response rate (IC-ORR) (Phase 1 and Phase 2), Maximum concentration of repotrectinib in plasma (Cmax), Overall Response Rate (ORR) (Phase 1), Overall survival (OS) (Phase 2), Progression-free survival (PFS) (Phase 2)
Oncology