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

NCT01184274 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-08-04

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • S*BIO

    collaborator INDUSTRY

  • NCIC Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Sylvain Baruchel · Hospital for Sick Children, Toronto Ontario Canada

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-01
Primary Completion
2012-04-12
Completion
2014-01-16

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01184274 on ClinicalTrials.gov