An Extension Study of ABT-806 in Subjects With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: ABT-806

• Registration Number: NCT01406119
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

This is an extension study of ABT-806 for subjects with advanced solid tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-08-01
• Study Start: 2011-10
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Subject has completed a prior study utilizing ABT-806 or 111ln ABT-806 (ABT 806i) and the Investigator believes that continued treatment with ABT-806 is in the best interest of the subject.
• Women of childbearing potential and men must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and for a period of 3 months. Female subjects considered not of childbearing potential must be documented as being surgically sterile or post-menopausal for at least 1 year.
• Subject is capable of understanding and complying with parameters as outlined in the protocol and the subject or the subject's legal acceptable representative is able to sign informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any or study-specific procedures.

Exclusion Criteria

• Subject discontinued ABT-806 or111ln ABT-806 (ABT-806i) administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).
• Subject has any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
• Subject is a lactating or pregnant female.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABT-806 Arm	ABT-806	-

Primary Outcome Measures

Name	Time	Method
Safety (Number of subjects with adverse events)	At each treatment visit (every other week throughout the study or up to 51 weeks)	Evaluation of vitals signs, clinical lab testing and adverse event monitoring (every other week), physical exam (every 4 weeks) and ECG (at final visit)
Pharmacokinetic profile (assay for ABT-806)	Every 8 weeks starting at Week 9 throughout the study or up to 51 weeks	Assay for ABT-806

Trial Locations

Locations (4)

Site Reference ID/Investigator# 58883; 🇺🇸 Baltimore, Maryland, United States

Site Reference ID/Investigator# 58882; 🇺🇸 Boston, Massachusetts, United States

Site Reference ID/Investigator# 60619; 🇦🇺 Heidelberg, Australia

Site Reference ID/Investigator# 63845; 🇦🇺 Herston, Australia