A Study to Assess the Effect of Rifampin on the Metabolism of Navitoclax

Phase 1

Completed

• Conditions: Lymphoma, Including Chronic Lymphocytic Leukemia; Solid Tumors
• Interventions: Drug: navitoclax; Drug: Rifampin

• Registration Number: NCT01121133
• Lead Sponsor: AbbVie

Brief Summary

This is an open-label, single or multiple center study to determine the interaction of rifampin with navitoclax (ABT-263) in approximately 12 subjects with cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-12
• Status Verified: 2011-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A (navitoclax and rifampin)	Rifampin	-
Arm A (navitoclax and rifampin)	navitoclax	-

Primary Outcome Measures

Name	Time	Method
To determine the effect of rifampin on the pharmacokinetics of navitoclax.	Weekly

Secondary Outcome Measures

Name	Time	Method
To determine the safety of navitoclax when administered alone and in combination with rifampin in these patients.	Daily