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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01406119
First Posted: August 1, 2011
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  Purpose
This is an extension study of ABT-806 for subjects with advanced solid tumors.

Condition Intervention Phase
Advanced Solid Tumors Drug: ABT-806 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Study of ABT-806 for Subjects With Advanced Solid Tumors

Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • Safety (Number of subjects with adverse events) [ Time Frame: 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) [ Time Frame: Every 8 weeks starting at Week 9 throughout the study or up to 51 weeks ]
    Assay for ABT-806


Enrollment: 14
Study Start Date: October 2011
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-806 Arm Drug: ABT-806
ABT-806 will be administered by intravenous infusion.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406119


Locations
United States, Maryland
Site Reference ID/Investigator# 58883
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Site Reference ID/Investigator# 58882
Boston, Massachusetts, United States, 02215
Australia
Site Reference ID/Investigator# 60619
Heidelberg, Australia, 3084
Site Reference ID/Investigator# 63845
Herston, Australia, 4029
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Christopher Ocampo, MD AbbVie
  More Information

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01406119     History of Changes
Other Study ID Numbers: M12-326
First Submitted: July 28, 2011
First Posted: August 1, 2011
Last Update Posted: January 27, 2017
Last Verified: January 2017