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

NCT01406119 | Completed Phase 1

• 1 other identifier: M12-326
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Safety (Number of subjects with adverse events)

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

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

• Pharmacokinetic profile (assay for ABT-806)

  Assay for ABT-806

  Every 8 weeks starting at Week 9 throughout the study or up to 51 weeks

Study Arms (1)

ABT-806 Arm

EXPERIMENTAL

Drug: ABT-806

Interventions

ABT-806 DRUG

ABT-806 will be administered by intravenous infusion.

ABT-806 Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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or111ln ABT-806 (ABT-806i) administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (4)

Site Reference ID/Investigator# 58883

Baltimore, Maryland, 21231, United States

Location

Site Reference ID/Investigator# 58882

Boston, Massachusetts, 02215, United States

Location

Site Reference ID/Investigator# 60619

Heidelberg, 3084, Australia

Location

Site Reference ID/Investigator# 63845

Herston, 4029, Australia

Location

MeSH Terms

Interventions

depatuxizumab

Study Officials

• Christopher Ocampo, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: August 1, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

US (2); AU (2)