Advanced Solid Tumors
Conditions
Brief summary
This is an extension study of ABT-806 for subjects with advanced solid tumors.
Interventions
DRUGABT-806
ABT-806 will be administered by intravenous infusion.
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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or111ln ABT-806 (ABT-806i) administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (Number of subjects with adverse events) | 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) |
| Pharmacokinetic profile (assay for ABT-806) | Every 8 weeks starting at Week 9 throughout the study or up to 51 weeks | Assay for ABT-806 |
Countries
Australia, United States
Outcome results
None listed