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

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

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

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: ABT-806

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Heidelberg, Australia, 3084
    • Site Reference ID/Investigator# 60619
  • Herston, Australia, 4029
    • Site Reference ID/Investigator# 63845
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Site Reference ID/Investigator# 58883
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Site Reference ID/Investigator# 58882

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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or111ln ABT-806 (ABT-806i) administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABT-806 Arm	Drug: ABT-806; ABT-806 will be administered by intravenous infusion.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Investigators: Study Director: Christopher Ocampo, MD, AbbVie

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: July 28, 2011
• First Submitted That Met QC Criteria: July 28, 2011
• First Posted (Estimate): August 1, 2011

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: M12-326