A Phase 1 Study of ABT-869 in Subjects With Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: ABT-869

• Registration Number: NCT00718380
• Lead Sponsor: AbbVie

Brief Summary

The objective of this study is to evaluate the pharmacokinetics, safety and tolerability of ABT-869 in Japanese patients with solid tumors up to the Recommended Phase Two Dose that was determined in a previous the M04-710 study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-17
• Study First Posted: 2008-07-18
• Study Start: 2008-09
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-07
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 3	ABT-869	Open label 0.20 mg/kg once a day dosing after safety evolution of Group 2
Group 1	ABT-869	Dose escalation from Open label 0.05 to 0.25 mg/kg once a day dosing for 21 days
Group 4	ABT-869	Open label 0.25 mg/kg once a day dosing after safety evolution of Group 3
Group 2	ABT-869	Open label 0.10 mg/kg once a day dosing after safety evolution of Group 1

Primary Outcome Measures

Name	Time	Method
Safety tolerability assessment	Weekly assessment for 3 weeks then every 3 weeks or more frequently as needed
Dose limiting toxicity determination	Weekly assessment for the first 3 weeks
Pharmacokinetic profile evaluation	Day 1 and Day 15

Secondary Outcome Measures

Name	Time	Method
Preliminary tumor response	Every 6 week