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: May 2, 2014
Last verified: May 2014

July 28, 2011
May 2, 2014
October 2011
June 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01406119 on ClinicalTrials.gov Archive Site
Not Provided
There are no secondary outcomes to report. [ Time Frame: There are no secondary outcomes to report. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
Drug: ABT-806
ABT-806 will be administered by intravenous infusion.
Experimental: ABT-806 Arm
Intervention: Drug: ABT-806
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
December 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT01406119
M12-326
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Kyle D. Holen, MD AbbVie
AbbVie
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP