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

NCT ID: NCT01406119

Last Updated: 2017-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2017-01-31

Brief Summary

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

Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABT-806 Arm

Group Type EXPERIMENTAL

ABT-806

Intervention Type DRUG

ABT-806 will be administered by intravenous infusion.

Interventions

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ABT-806

ABT-806 will be administered by intravenous infusion.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Ocampo, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 58883

Baltimore, Maryland, United States

Site Status

Site Reference ID/Investigator# 58882

Boston, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 60619

Heidelberg, , Australia

Site Status

Site Reference ID/Investigator# 63845

Herston, , Australia

Site Status

Countries

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United States Australia

Other Identifiers

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M12-326

Identifier Type: -

Identifier Source: org_study_id

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