Advanced Solid TumorsPhase 1NCT01406119
An Extension Study of ABT-806 in Subjects With Advanced Solid Tumors
A Phase 1 study testing ABT-806 in people with Advanced Solid Tumors, run by AbbVie (prior sponsor, Abbott) at 4 sites in 2 countries.
Trial summary
This is an extension study of ABT-806 for subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- ABT-806
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Oct 2011to Jan 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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or111ln ABT-806 (ABT-806i) administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Site Reference ID/Investigator# 58883
Baltimore, Maryland, 21231
Site Reference ID/Investigator# 58882
Boston, Massachusetts, 02215
Australia2 sites
Site Reference ID/Investigator# 60619
Heidelberg, 3084
Site Reference ID/Investigator# 63845
Herston, 4029
About this study
Official title: An Extension Study of ABT-806 for Subjects With Advanced Solid Tumors
This is an extension study of ABT-806 for subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- ABT-806
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-806Drug
ABT-806 will be administered by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| ABT-806 Arm | Experimental | Not described Receives: Drug: ABT-806 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Every 8 weeks starting at Week 9 throughout the study or up to 51 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Ocampo, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406119
- Sponsor's protocol ID
- M12-326
- Status last verified
- Jan 2017
- First submitted
- 28 Jul 2011
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study of ABT-806 for Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01406119
- Acronym / sponsor ID
- M12-326
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an extension study of ABT-806 for subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABT-806 Arm | Experimental | Drug: ABT-806 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-806ABT-806 will be administered by intravenous infusion. | Drug | ABT-806 Arm |
Primary outcome
Safety (Number of subjects with adverse events)
Time frame: 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)
Time frame: Every 8 weeks starting at Week 9 throughout the study or up to 51 weeks
Assay for ABT-806
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Ocampo, MD study director
AbbVie
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-806 in people with Advanced Solid Tumors, run by AbbVie (prior sponsor, Abbott) at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Number of subjects with adverse events) (time frame: At each treatment visit (every other week throughout the study or up to 51 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2017.