Phase 1/2 Open Label solid tumour Safety and Tolerability study in Pediatric and Young Adult

• Research type

  Research Study

• Full title

  A Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics, and Antitumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects with Advanced or Metastatic Malignancies Harboring ALK, ROS1, or NTRK1-3 Alterations (CARE)

• IRAS ID

  1009259

• Contact name

  GSM-CT Representative

• Contact email

  gsm-ct@bms.com

• Sponsor organisation

  Turning Point Therapeutics, Inc. (a wholly owned subsidiary of Bristol Myers Squibb Company)

• Eudract number

  2019-003055-11

• Clinicaltrials.gov Identifier

  NCT04094610

• Research summary

  This is an open-label, phase 1/2 study in Pediatric and Young Adult Subjects with Advanced or Metastatic Malignancies. The study
  is designed to further define the safety and pharmacokinetic profiles of single agent repotrectinib at the Recommended Phase 2 Dose. All subjects in Phase 2 will receive repotrectinib regardless of food intake orally either once a day or twice a day at the Recommended Phase 2 Dose and schedule for 28 consecutive days in repeated 4-week cycles.

• REC name

  West of Scotland REC 1

• REC reference

  24/WS/0035

• Date of REC Opinion

  13 Jun 2024

• REC opinion

  Further Information Favourable Opinion