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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406119
• Other study ID #: M12-326
• Status: Completed
• Phase: Phase 1
• First received: July 28, 2011
• Last updated: January 26, 2017
• Start date: October 2011
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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or111ln ABT-806 (ABT-806i) administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• ABT-806
ABT-806 will be administered by intravenous infusion.

Locations

Country	Name	City	State
Australia	Site Reference ID/Investigator# 60619	Heidelberg
Australia	Site Reference ID/Investigator# 63845	Herston
United States	Site Reference ID/Investigator# 58883	Baltimore	Maryland
United States	Site Reference ID/Investigator# 58882	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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