Squamous Cell TumorsPhase 1NCT01741727
A Study of ABT-414 in Subjects With Solid Tumors
A Phase 1 study testing ABT-414 in people with Squamous Cell Tumors, run by AbbVie (prior sponsor, Abbott) at 6 sites in 2 countries.
Trial summary
A study of ABT-414 in subjects with solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Squamous Cell Tumors
- What is being tested?
- ABT-414
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2012to Nov 2015
- 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
- Subjects must have a solid tumor type likely to over-express Epidermal Growth Factor Receptor (EGFR) (Phase 1)
- Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Subjects have available tumor tissue
- Subjects have adequate bone marrow, renal, and hepatic function as follows: Bone marrow: Absolute neutrophil count (ANC) >/= 1,500/mm3 Platelets >/= 100,000/mm3; Hemoglobin >/= 9.0 g/dL Renal function: Serum creatinine </= 1.5 times the upper limit of the institution's normal range Hepatic function: Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) </= 1.5 times the upper limit of the institution's normal range. Subjects with liver metastasis may have an AST and ALT of </= 5.0 x the upper limit of normal.
- Subjects in the Phase 2 portion must have squamous cell Non-Small Cell Lung Cancer (NSCLC)
- Eligibility is restricted to subjects with confirmed EGFR amplification in the EGFR amplified cohort
Who cannot join
- The subject has uncontrolled metastases to the central nervous system (CNS). Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 28 days after definitive therapy and have not received prior whole brain radiation (Phase 1 only).
- The subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 28 days prior to the first dose of ABT-414.
- The subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
- The subject had had major surgery within 28 days prior to the first dose of ABT-414.
- The subject has a history of immunologic reaction to any Immunoglobulin G (IgG) containing agent.
- Phase 2 portion only: The subject has previous or concurrent cancer that is distinct in primary site or histology from NSCLC, except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Site Reference ID/Investigator# 117516
Boston, Massachusetts, 02215
Site Reference ID/Investigator# 83154
Boston, Massachusetts, 02215
Site Reference ID/Investigator# 83156
Chicago, Illinois, 60637
Site Reference ID/Investigator# 83155
San Antonio, Texas, 78229
Site Reference ID/Investigator# 90333
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-414 in Subjects With Advanced Solid Tumors Likely to Over-Express the Epidermal Growth Factor Receptor (EGFR)
A study of ABT-414 in subjects with solid tumors.
- Conditions
- Squamous Cell Tumors
- Being tested
- ABT-414
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-414Drug
ABT-414 will be administered by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| ABT-414 | Experimental | Subjects with solid tumors (Phase 1) and squamous non-small cell lung cancer (NSCLC) (Phase 2) Receives: Drug: ABT-414 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 - Safety (Number of subjects with adverse events and/or dose limiting toxicities)
Evaluation of vital signs, clinical lab testing, adverse event monitoring, physical exam and electrocardiogram (ECG) (periodic) under different dosing schedules, drug infusion times, and manufacturing processes.
Measured: Every 1-3 weeks for an average of 20 weeks
Phase 1 - Pharmacokinetic profile
Cmax, Cmin, and half-life
Measured: Multiple timepoints Week 1 and Week 7
Phase 2 - Efficacy
Objective response per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST)
Measured: Every 6-9 weeks for an average of 20 weeks
Secondary outcomes (3)
Phase 2- Safety (Scheduled study visits occurring on average every 3 weeks)
Evaluation of vital signs, clinical lab testing, and adverse event monitoring, physical exam, and electrocardiogram (periodic)
Measured: Followed on average every 3 weeks for approximately 20 weeks
Phase 2- Pharmacokinetic profile
Cmax, Cmin, and half-life
Measured: Multiple timepoints Week 1
Phase 1&2 - QT assessment
Triplicate electrocardiograms
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2015
- Study completionNov 2015
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 Squamous Cell 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
- 57 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
- NCT01741727
- Sponsor's protocol ID
- M13-379
- Status last verified
- Feb 2016
- First submitted
- 19 Sep 2012
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Munasinghe WP, Mittapalli RK, Li H, Hoffman DM, Holen KD, Menon RM, Xiong H. Evaluation of the effect of the EGFR antibody-drug conjugate ABT-414 on QT interval prolongation in patients with advanced solid tumors likely to over-express EGFR. Cancer Chemother Pharmacol. 2017 May;79(5):915-922. doi: 10.1007/s00280-017-3284-y. Epub 2017 Mar 27.
PubMed 28349167
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-414 in Subjects With Advanced Solid Tumors Likely to Over-Express the Epidermal Growth Factor Receptor (EGFR)
- ClinicalTrials.gov ID
- NCT01741727
- Acronym / sponsor ID
- M13-379
- Conditions
- Squamous Cell Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Dec 2012 (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.
A study of ABT-414 in subjects with 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-414 | Experimental | Drug: ABT-414Subjects with solid tumors (Phase 1) and squamous non-small cell lung cancer (NSCLC) (Phase 2) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must have a solid tumor type likely to over-express Epidermal Growth Factor Receptor (EGFR) (Phase 1)
- Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Subjects have available tumor tissue
- Subjects have adequate bone marrow, renal, and hepatic function as follows: Bone marrow: Absolute neutrophil count (ANC) >/= 1,500/mm3 Platelets >/= 100,000/mm3; Hemoglobin >/= 9.0 g/dL Renal function: Serum creatinine </= 1.5 times the upper limit of the institution's normal range Hepatic function: Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) </= 1.5 times the upper limit of the institution's normal range. Subjects with liver metastasis may have an AST and ALT of </= 5.0 x the upper limit of normal.
- Subjects in the Phase 2 portion must have squamous cell Non-Small Cell Lung Cancer (NSCLC)
Key exclusion criteria (6 listed)
- The subject has uncontrolled metastases to the central nervous system (CNS). Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 28 days after definitive therapy and have not received prior whole brain radiation (Phase 1 only).
- The subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 28 days prior to the first dose of ABT-414.
- The subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
- The subject had had major surgery within 28 days prior to the first dose of ABT-414.
- The subject has a history of immunologic reaction to any Immunoglobulin G (IgG) containing agent.
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-414ABT-414 will be administered by intravenous infusion. | Drug | ABT-414 |
Primary outcome
Phase 1 - Safety (Number of subjects with adverse events and/or dose limiting toxicities)
Time frame: Every 1-3 weeks for an average of 20 weeks
Evaluation of vital signs, clinical lab testing, adverse event monitoring, physical exam and electrocardiogram (ECG) (periodic) under different dosing schedules, drug infusion times, and manufacturing processes.
Phase 1 - Pharmacokinetic profile
Time frame: Multiple timepoints Week 1 and Week 7
Cmax, Cmin, and half-life
Phase 2 - Efficacy
Time frame: Every 6-9 weeks for an average of 20 weeks
Objective response per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST)
3 secondary outcomes
Phase 2- Safety (Scheduled study visits occurring on average every 3 weeks)
Time frame: Followed on average every 3 weeks for approximately 20 weeks
Phase 2- Pharmacokinetic profile
Time frame: Multiple timepoints Week 1
Phase 1&2 - QT assessment
Time frame: Week 1
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 20 Nov 2017.
- Results publication: PubMed 28349167Munasinghe WP, Mittapalli RK, Li H, Hoffman DM, Holen KD, Menon RM, Xiong H. Evaluation of the effect of the EGFR antibody-drug conjugate ABT-414 on QT interval prolongation in patients with advanced solid tumors likely to over-express EGFR. Cancer Chemother Pharmacol. 2017 May;79(5):915-922. doi: 10.1007/s00280-017-3284-y. Epub 2017 Mar 27.
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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
6 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-414 in people with Squamous Cell Tumors, run by AbbVie (prior sponsor, Abbott) at 6 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 6 inclusion and 6 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 20 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 6 sites in United States, Canada. 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?
Phase 1 - Safety (Number of subjects with adverse events and/or dose limiting toxicities) (time frame: Every 1-3 weeks for an average of 20 weeks). 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 NCT01741727, 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 20 Nov 2017; AzTrials last refreshed its copy on 6 Nov 2026.