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

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.
 
ClinicalTrials.gov Identifier: NCT01406119
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Tracking Information
First Submitted Date  ICMJE July 28, 2011
First Posted Date  ICMJE August 1, 2011
Last Update Posted Date January 27, 2017
Study Start Date  ICMJE October 2011
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
There are no secondary outcomes to report. [ Time Frame: There are no secondary outcomes to report. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Extension Study of ABT-806 in Subjects With Advanced Solid Tumors
Official Title  ICMJE An Extension Study of ABT-806 for Subjects With Advanced Solid Tumors
Brief Summary This is an extension study of ABT-806 for subjects with advanced solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE Drug: ABT-806
ABT-806 will be administered by intravenous infusion.
Study Arms  ICMJE Experimental: ABT-806 Arm
Intervention: Drug: ABT-806
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2017)
14
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2011)
60
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01406119
Other Study ID Numbers  ICMJE M12-326
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie ( AbbVie (prior sponsor, Abbott) )
Study Sponsor  ICMJE AbbVie (prior sponsor, Abbott)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Christopher Ocampo, MD AbbVie
PRS Account AbbVie
Verification Date January 2017

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