Clinical Trial: A Two-Part Study of TB-403 in Pediatric Subjects With Relapsed or Refractory Medulloblastoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Two-Part Study of TB-403 in Pediatric Subjects With Relapsed or Refractory Medulloblastoma
Brief Summary: The purpose of this study is to assess the safety and tolerability profile of TB-403 (humanized monoclonal antibody against placental growth factor (PlGF)) in pediatric subjects with relapsed or refractory Medulloblastoma.
Detailed Summary:
The study will be conducted in 2 parts.
In part A, the maximum tolerated dose of TB-403 will be determined in pediatric subjects with relapsed or refractory Medulloblastoma (MB) and as well Neuroblastoma (NB), Ewing Sarcoma (ES) and Alveolar Rhabdomyosarcoma (ARMS).
In part B of the clinical trial, the safety and tolerability of TB-403 at the maximum tolerated dose will be evaluated in pediatric subjects with relapsed or refractory Medulloblastoma.
Sponsor: Oncurious NV
Current Primary Outcome: In Part A, the primary safety endpoint will be the determination of the maximum tolerated dose (MTD) / study maximum dose (SMD) based on the occurrence of dose-limiting toxicities (DLTs) during the 28-day DLT assessment period. [ Time Frame: Day28 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- TB-403 total exposure (AUC∞) after single ascending dose [ Time Frame: Day 1, day 4, day 8, day 14, day 28, day 56, day 112, day 168 and day 308. ]
- TB-403 Dose/CL after single ascending dose [ Time Frame: Day 1, day 4, day 8, day 14, day 28, day 56, day 112, day 168 and day 308. ]
- TB-403 Volume of the central compartment (Vc) after single ascending dose [ Time Frame: Day 1, day 4, day 8, day 14, day 28, day 56, day 112, day 168 and day 308. ]
- TB-403 Volume of distribution at steady-state (Vss) after single ascending dose [ Time Frame: Day 1, day 4, day 8, day 14, day 28, day 56, day 112, day 168 and day 308. ]
- TB-403 terminal half-life (t½,z) after single ascending dose [ Time Frame: Day 1, day 4, day 8, day 14, day 28, day 56, day 112, day 168 and day 308. ]
Original Secondary Outcome: Same as current
Information By: Oncurious NV
Dates:
Date Received: April 8, 2016
Date Started: May 2016
Date Completion: December 2018
Last Updated: February 21, 2017
Last Verified: February 2017