A Study of BBI608 in Adult Patients With Advanced Malignancies

Phase 1

Completed

• Conditions: Cancer, Advanced Malignancies
• Interventions: Drug: BBI608

• Registration Number: NCT01775423
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief Summary

This is an open label, single arm, dose escalation study of BBI608 in patients with advanced malignancies.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-25
• Primary Completion: 2015-08-06
• Study Completion: 2015-08-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BBI608	BBI608	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Adverse events will be assessed at baseline, while the participant is taking BBI608, and for 30 days after stopping therapy. The average length of this duration is expected to be approximately 4 months.	Assessment of safety of BBI608 given in monotherapy to patients with advanced malignancies by reporting of adverse events and serious adverse events

Trial Locations

Locations (3)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

Institute for Translational Oncology Research, Greenville Hospital System; 🇺🇸 Greenville, South Carolina, United States

Ottawa Hospital Cancer Center; 🇨🇦 Ottawa, Ontario, Canada