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

Phase 1
18 Years
Open (Enrolling)
Advanced Solid Tumors

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Trial Information

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

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completing the prior study (due to disease progression, toxicity, withdrawn consent,

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety (Number of subjects with adverse events)

Outcome Description:

Evaluation of vitals signs, clinical lab testing and adverse event monitoring (every other week), physical exam (every 4 weeks) and ECG (at final visit)

Outcome Time Frame:

At each treatment visit (every other week throughout the study or up to 51 weeks)

Safety Issue:


Principal Investigator

Kyle D. Holen, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2011

Completion Date:

December 2013

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms



Site Reference ID/Investigator# 58882Boston, Massachusetts  02215
Site Reference ID/Investigator# 58883Baltimore, Maryland  21231