NCT01184274

A Phase I Study of SB939 in Pediatric Patients With Refractory Solid Tumours and Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 12 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being done because SB939 has been shown to shrink tumours in animals and in some people and seems promising, but we are not sure if it can offer better results than standard treatment.

Detailed description

In Part A of this study, SB939 was given to children with solid tumours. The purpose of Part A of this study is to ind the highest dose of a new drug SB939 that can be giben to children without causing very severe side effects that are tolerable. In Part B of this study, SB939 will be given to children with leukemia. The purpose of Part B, is to see whether the dose that was determined to be the best dose for patients with solid tumours is also the best dose for children with leukemia. In Part C of this study, SB939 will be given together with 13-cis-retinoic acid. The purpose of Part C, is to see whether the SB939 dose that was determined to be the best dose in Part A is also the best dose when given in combination with 13-cis-retinoic acid.

Conditions

• Leukemia
• Solid Tumours

Interventions

Type	Name	Description
DRUG	SB939	Dose Levels for Part A -1 - 20mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing 1. (starting dose) 25mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing 2. \- 35mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing 3. \- 45mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing 4+ - Previous level + 10mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-04-12
• Completion: 2014-01-16
• First posted: 2010-08-18
• Last updated: 2023-08-04

Locations

8 sites across 1 country: Canada