Clinical Trial: Study of RXDX-101 in Children With Recurrent or Refractory Solid Tumors and Primary CNS Tumors, With or Without TRK, ROS1, or ALK Fusions

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 1/1b, Open-Label, Dose-Escalation and Expansion Study of Entrectinib (RXDX 101) in Children and Adolescents With Recurrent or Refractory Solid Tumors and Primary CNS Tumors, With or Without TR

Brief Summary: This is a 5-part, open-label, Phase 1/1b multicenter, dose escalation study in pediatric patients with relapsed refractory solid tumors; 2) primary CNS tumors; 3) neuroblastoma; 4) non-neuroblastoma, extracranial solid tumors with NTRK1/2/3, ROS1 or ALK gene rearrangements; and 5) patients who are otherwise eligible but unable to swallow capsules. The study is designed to explore the safety, maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), pharmacokinetics, and antitumor activity of entrectinib.

Detailed Summary:
Sponsor: Ignyta, Inc.

Current Primary Outcome:

• Maximum Tolerated Dose (MTD) [ Time Frame: Approximately 6 months ]
  Assessed by National Cancer Institute Common Terminology for Adverse Events Criteria (NCI CTCAE v4.03)
• Recommended Phase 2 Dose (RP2D) [ Time Frame: Approximately 6 months ]
  Assessed by NCI CTCAE v4.03

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Safety and Tolerability - AE, ECG and Labs assessed by NCI CTCAE v4.03 [ Time Frame: Approximately 24 months ]
  AE, ECG and Labs assessed by NCI CTCAE v4.03
• Maximum observed plasma drug concentration (Cmax) [ Time Frame: Approximately 24 months ]
  Assessed by plasma concentrations obtained Day 1 (Cycles 1 and 2)
• Time to Cmax, by inspection (Tmax) [ Time Frame: Approximately 24 months ]
  Assessed by plasma concentrations obtained Day 1 (Cycles 1 and 2)
• Css [ Time Frame: Approximately 24 months ]
  Assessed by plasma concentrations obtained Day 1 (Cycles 1 and 2)
• Terminal half life (t½) [ Time Frame: Approximately 24 months ]
  Assessed by plasma concentrations obtained Day 1 (Cycles 1 and 2)
• Area under the drug concentration by time curve (AUC) [ Time Frame: Approximately 24 months ]
  Assessed by plasma concentrations obtained Day 1 (Cycles 1 and 2)
• Objective Response Rate (ORR) [ Time Frame: Approximately 24 months ]
  Assessed by RECIST v1.1
• Progression-free Survival (PFS) [ Time Frame: Approximately 24 months ]
  Defined as time from the date of study enrollment to the first occurrence of objective disease progression or date of death due to any cause, whichever occurs first

Original Secondary Outcome: Same as current

Information By: Ignyta, Inc.

Dates:
Date Received: January 4, 2016
Date Started: December 2015
Date Completion: March 2019
Last Updated: March 14, 2017
Last Verified: March 2017