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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01406119




Trial ID
NCT01406119
Ethics application status
Date submitted
28/07/2011
Date registered
28/07/2011
Date last updated
26/01/2017

Titles & IDs
Public title
An Extension Study of ABT-806 in Subjects With Advanced Solid Tumors
Scientific title
An Extension Study of ABT-806 for Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
M12-326
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABT-806

Experimental: ABT-806 Arm -


Treatment: Drugs: ABT-806
ABT-806 will be administered by intravenous infusion.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
At each treatment visit (every other week throughout the study or up to 51 weeks)
Primary outcome [2] 0 0
Pharmacokinetic profile (assay for ABT-806) - Assay for ABT-806
Timepoint [2] 0 0
Every 8 weeks starting at Week 9 throughout the study or up to 51 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 60619 - Heidelberg
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 63845 - Herston
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an extension study of ABT-806 for subjects with advanced solid tumors.
Trial website
https://clinicaltrials.gov/show/NCT01406119
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Ocampo, MD
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries