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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01406119
First received: July 28, 2011
Last updated: January 16, 2014
Last verified: January 2014
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Extension Study of ABT-806 for Subjects With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by AbbVie:

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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Assay for ABT-806


Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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: Kyle D. Holen, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01406119     History of Changes
Other Study ID Numbers: M12-326
Study First Received: July 28, 2011
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 15, 2014