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Completed

NCT Number: NCT01406119

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

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

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 60619, Heidelberg, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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or111ln ABT-806 (ABT-806i) administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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

Treatment and study plan

ABT-806

Drug

ABT-806 will be administered by intravenous infusion.

Primary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Aug 1, 2011
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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