Advanced Solid TumorsPhase 1NCT01255657
A Study of ABT-806 in Subjects With Advanced Solid Tumor Types
A Phase 1 study testing ABT-806 in people with Advanced Solid Tumors, run by AbbVie (prior sponsor, Abbott) at 3 sites in United States.
Trial summary
This is an open-label study designed to determine the recommended Phase 2 dose (RPTD) and evaluate the safety and pharmacokinetics of ABT-806 in 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
- 49 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2010to Nov 2012
- 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 a solid tumor of a type known to either over-express wild-type EGFR or to express variant III mutant EGFR (e.g., head and neck squamous cell carcinoma, non small cell lung cancer (NSCLC), colorectal carcinoma) or a tumor known to be EGFR positive.
- Subject must have disease that is not amenable to surgical resection or other approved therapeutic options with curative intent.
- Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
- Inclusion criteria for Expand Safety Cohort B - subject has histologically confirmed supratentorial glioblastoma multiforme (GBM) .
Who cannot join
- Subject has uncontrolled metastases to the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 1 month after definitive therapy. Subjects with glioblastoma multiforme (GBM) are excluded from the dose escalation portion of the study, but may be enrolled in the expanded safety cohort.
- Subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 21 days prior to the first dose of ABT-806.
- Subject has had any adjustments of an ongoing steroid medication during the 14 days prior to the first dose of ABT-806.
- Subject has received a prior EGFR-directed monoclonal antibody within a period of 4 weeks prior to the first dose of ABT-806.
- Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Site Reference ID/Investigator# 54056
Baltimore, Maryland, 21231
Site Reference ID/Investigator# 41931
Boston, Massachusetts, 02215
Site Reference ID/Investigator# 43422
Tacoma, Washington, 98405
About this study
Official title: A Phase 1 Study of ABT-806 in Subjects With Advanced Solid Tumor Types Likely to Either Overexpress Wild-Type Epidermal Growth Factor Receptor (EGFR) or to Express Variant III Mutant EGFR
This is an open-label study designed to determine the recommended Phase 2 dose (RPTD) and evaluate the safety and pharmacokinetics of ABT-806 in 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 and/or dose-limiting toxicities)
Evaluation of vital signs, clinical lab testing and adverse event monitoring (every other week), physical exam (every 4 weeks) and ECG (periodic)
Measured: At each treatment visit (weekly for first 4 weeks and then at least every 4 weeks through end of treatment)
Pharmacokinetic profile (assay for ABT-806) Dose Escalation Cohort
Assay for ABT-806
Measured: Week 1, 2, 3, 5, 7, 8, 9, 11, 13, 15, 19, 23 and Final Visit
Pharmacokinetic profile (assay for ABT-806) Expanded Safety Cohort
Assay for ABT-806
Measured: Week 1, 3, 5, 7, 11, 13, 15, 19, 23 and 30 Day Follow-up
Secondary outcomes (4)
Pharmacokinetic profile (assay for Anti-drug Antibody) Dose Escalation Cohort
Assay for Anti-drug antibody against ABT-806
Measured: Week 1, 3, 7, 11, 15, 19, 23 and Final Visit
QT assessment
Triplicate ECGs
Measured: Week 1, 7, 13, and 30 day follow-up visit
Infusion rate evaluation (Expanded Safety Cohort)
Two infusion times explored
Measured: Every other week
Pharmacokinetic profile (assay for Anti-drug Antibody) Expanded Safety Cohort
Assay for Anti-drug antibody against ABT-806
Measured: Week 1, 3, 7, 11, 15, 19, 23 and 30 Day Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyle D. Holen, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255657
- Sponsor's protocol ID
- M11-847
- Status last verified
- Jan 2013
- First submitted
- 22 Nov 2010
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Sharma S, Mittapalli RK, Holen KD, Xiong H. Population Pharmacokinetics of ABT-806, an Investigational Anti-Epidermal Growth Factor Receptor (EGFR) Monoclonal Antibody, in Advanced Solid Tumor Types Likely to Either Over-Express Wild-Type EGFR or Express Variant III Mutant EGFR. Clin Pharmacokinet. 2015 Oct;54(10):1071-81. doi: 10.1007/s40262-015-0258-2.
PubMed 25761639
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of ABT-806 in Subjects With Advanced Solid Tumor Types Likely to Either Overexpress Wild-Type Epidermal Growth Factor Receptor (EGFR) or to Express Variant III Mutant EGFR
- ClinicalTrials.gov ID
- NCT01255657
- Acronym / sponsor ID
- M11-847
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 7 Dec 2010 (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 open-label study designed to determine the recommended Phase 2 dose (RPTD) and evaluate the safety and pharmacokinetics of ABT-806 in subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (5 listed)
- Subject has a solid tumor of a type known to either over-express wild-type EGFR or to express variant III mutant EGFR (e.g., head and neck squamous cell carcinoma, non small cell lung cancer (NSCLC), colorectal carcinoma) or a tumor known to be EGFR positive.
- Subject must have disease that is not amenable to surgical resection or other approved therapeutic options with curative intent.
- Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
- Inclusion criteria for Expand Safety Cohort B - subject has histologically confirmed supratentorial glioblastoma multiforme (GBM) .
Key exclusion criteria (5 listed)
- Subject has uncontrolled metastases to the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 1 month after definitive therapy. Subjects with glioblastoma multiforme (GBM) are excluded from the dose escalation portion of the study, but may be enrolled in the expanded safety cohort.
- Subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 21 days prior to the first dose of ABT-806.
- Subject has had any adjustments of an ongoing steroid medication during the 14 days prior to the first dose of ABT-806.
- Subject has received a prior EGFR-directed monoclonal antibody within a period of 4 weeks prior to the first dose of ABT-806.
- Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
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 and/or dose-limiting toxicities)
Time frame: At each treatment visit (weekly for first 4 weeks and then at least every 4 weeks through end of treatment)
Evaluation of vital signs, clinical lab testing and adverse event monitoring (every other week), physical exam (every 4 weeks) and ECG (periodic)
Pharmacokinetic profile (assay for ABT-806) Dose Escalation Cohort
Time frame: Week 1, 2, 3, 5, 7, 8, 9, 11, 13, 15, 19, 23 and Final Visit
Assay for ABT-806
Pharmacokinetic profile (assay for ABT-806) Expanded Safety Cohort
Time frame: Week 1, 3, 5, 7, 11, 13, 15, 19, 23 and 30 Day Follow-up
Assay for ABT-806
4 secondary outcomes
Pharmacokinetic profile (assay for Anti-drug Antibody) Dose Escalation Cohort
Time frame: Week 1, 3, 7, 11, 15, 19, 23 and Final Visit
QT assessment
Time frame: Week 1, 7, 13, and 30 day follow-up visit
Infusion rate evaluation (Expanded Safety Cohort)
Time frame: Every other week
Pharmacokinetic profile (assay for Anti-drug Antibody) Expanded Safety Cohort
Time frame: Week 1, 3, 7, 11, 15, 19, 23 and 30 Day Follow-up
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 21 Nov 2017.
- Results publication: PubMed 25761639Sharma S, Mittapalli RK, Holen KD, Xiong H. Population Pharmacokinetics of ABT-806, an Investigational Anti-Epidermal Growth Factor Receptor (EGFR) Monoclonal Antibody, in Advanced Solid Tumor Types Likely to Either Over-Express Wild-Type EGFR or Express Variant III Mutant EGFR. Clin Pharmacokinet. 2015 Oct;54(10):1071-81. doi: 10.1007/s40262-015-0258-2.
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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.
Kyle D. Holen, MD study director
AbbVie
3 sites in 1 country: 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 3 sites in United States.
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 5 inclusion and 5 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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 and/or dose-limiting toxicities) (time frame: At each treatment visit (weekly for first 4 weeks and then at least every 4 weeks through end of treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01255657, which also lists 1 linked publication.
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 21 Nov 2017.