This trial is active, not recruiting.

Condition advanced solid tumors
Treatment abt-806
Phase phase 1
Sponsor AbbVie (prior sponsor, Abbott)
Start date October 2011
End date December 2016
Trial size 30 participants
Trial identifier NCT01406119, M12-326


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
ABT-806 will be administered by intravenous infusion.

Primary Outcomes

Safety (Number of subjects with adverse events)
time frame: At each treatment visit (every other week throughout the study or up to 51 weeks)
Pharmacokinetic profile (assay for ABT-806)
time frame: Every 8 weeks starting at Week 9 throughout the study or up to 51 weeks

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

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or111ln ABT-806 (ABT-806i) administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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

Additional Information

Official title An Extension Study of ABT-806 for Subjects With Advanced Solid Tumors
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.