Advanced Solid TumorsPhase 1NCT01472016
Study of ABT-700 in Subjects With Advanced Solid Tumors
A Phase 1 study testing ABT-700, docetaxel and FOLFIRI in people with Advanced Solid Tumors, run by AbbVie (prior sponsor, Abbott).
Trial summary
This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-700 in subjects with advanced solid tumors that may have MET amplification or c-Met overexpression. ABT-700, previously known as h224G11 in publications, is an anti-c-Met antibody. 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-700, docetaxel and FOLFIRI
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2011to 27 Apr 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 with advanced solid tumors; Dose-expansion: evidence for MET gene amplification.
- Subject must have disease: a) that is not amenable to surgical resection, or b) that has progressed or recurred despite standard therapy, or c) that has failed to respond to standard therapy, or d) for which no effective therapy exists.
- Subject cannot tolerate or must not be eligible for other approved therapeutic options with known survival advantage.
- Subjects enrolled on the combination therapy phase must satisfy the above inclusion criteria and also the following: Subjects must have inoperable, locally advanced or metastatic cancer and be eligible to receive docetaxel or FOLFIRI/cetuximab or erlotinib in combination with ABT-700.
Who cannot join
- Subject has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days, or herbal therapy within 7 days prior to the first dose of ABT-700.
- Subjects with uncontrolled metastases of the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease after definitive therapy and have not used steroids for at least 1 month prior to first dose of ABT-700.
- Subject has unresolved adverse events > Grade 1 from prior anticancer therapy except for alopecia or anemia.
- Subject has had major surgery within 21 days prior to the first dose of ABT-700.
- Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive docetaxel or FOLFIRI/cetuximab or erlotinib per most current prescribing information, or at the discretion of the Investigator. Subjects with K-Ras mutation-positive colorectal cancer will be excluded from receiving FOLFIRI/cetuximab.
About this study
Official title: A Multi-Center, Phase 1/1b, Open-Label, Dose Escalation Study of ABT-700, a Monoclonal Antibody in Subjects With Advanced Solid Tumors
This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-700 in subjects with advanced solid tumors that may have MET amplification or c-Met overexpression. ABT-700, previously known as h224G11 in publications, is an anti-c-Met antibody. The early clinical development plan for ABT-700 is based on the activity demonstrated in preclinical models. Up to 124 subjects will be enrolled.
- Conditions
- Advanced Solid Tumors
- Keywords
- c-Met overexpression, MET amplification, Neoplasms, h224G11
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-700Drug
ABT-700 will be administered by intravenous infusion at escalating dose levels on day 1 in 21-day dosing cycles. Additional subjects will be enrolled in an dose expansion cohort that will further evaluate ABT-700.
docetaxelDrug
Docetaxel will be administered by intravenous infusion on Day 1 in 21-day dosing cycles.
FOLFIRIDrug
5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion on Day 1 and 15 in 28-day dosing cycles.
cetuximabDrug
Cetuximab will be administered by intravenous infusion weekly.
erlotinibDrug
Erlotinib will be taken orally daily.
ABT-700Drug
ABT-700 will be administered by intravenous infusion on Day 1 and Day 15 in 28-day dosing cycles.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | ABT-700 will be administered by intravenous infusion at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate ABT-700. Receives: Drug: ABT-700 |
| Cohort B | Experimental | ABT-700 plus docetaxel. Receives: Drug: ABT-700; Drug: docetaxel |
| Cohort C | Experimental | ABT-700 plus FOLFIRI/cetuximab Receives: Drug: ABT-700; Drug: FOLFIRI; Drug: cetuximab |
| Cohort D | Experimental | ABT-700 plus erlotinib Receives: Drug: ABT-700; Drug: erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
Evaluation of vital signs, clinical lab testing, physical exams and adverse event monitoring
Measured: First cycle of treatment through 60 day follow-up visit
To Evaluate the pharmacokinetics of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
Pharmacokinetic profile of ABT-700 analyzed from blood samples
Measured: At each cycle of treatment through 60 days after last dose.
To determine the recommended Phase 2 dose for ABT-700
Measured: First cycle of treatment through 60 day follow-up visit
Secondary outcomes (1)
To evaluate the preliminary efficacy of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
Objective response rate (complete and partial response), progression-free survival and duration of response
Measured: Screening through 60 day follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study start6 Oct 2011
- Primary completion27 Apr 2017
- Study completion27 Apr 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louie Naumovski, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472016
- Sponsor's protocol ID
- M12-375
- Status last verified
- Jun 2017
- First submitted
- 14 Oct 2011
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
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 Multi-Center, Phase 1/1b, Open-Label, Dose Escalation Study of ABT-700, a Monoclonal Antibody in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01472016
- Acronym / sponsor ID
- M12-375
- Conditions
- Advanced Solid Tumors
- Keywords
- c-Met overexpression, MET amplification, Neoplasms, h224G11
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2011 (actual)
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 16 Nov 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 a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-700 in subjects with advanced solid tumors that may have MET amplification or c-Met overexpression. ABT-700, previously known as h224G11 in publications, is an anti-c-Met antibody. The early clinical development plan for ABT-700 is based on the activity demonstrated in preclinical models. Up to 124 subjects will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: ABT-700ABT-700 will be administered by intravenous infusion at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate ABT-700. |
| Cohort B | Experimental | Drug: ABT-700, Drug: docetaxelABT-700 plus docetaxel. |
| Cohort C | Experimental | Drug: ABT-700, Drug: FOLFIRI, Drug: cetuximabABT-700 plus FOLFIRI/cetuximab |
| Cohort D | Experimental | Drug: ABT-700, Drug: erlotinibABT-700 plus erlotinib |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject with advanced solid tumors; Dose-expansion: evidence for MET gene amplification.
- Subject must have disease: a) that is not amenable to surgical resection, or b) that has progressed or recurred despite standard therapy, or c) that has failed to respond to standard therapy, or d) for which no effective therapy exists.
- Subject cannot tolerate or must not be eligible for other approved therapeutic options with known survival advantage.
- Subjects enrolled on the combination therapy phase must satisfy the above inclusion criteria and also the following: Subjects must have inoperable, locally advanced or metastatic cancer and be eligible to receive docetaxel or FOLFIRI/cetuximab or erlotinib in combination with ABT-700.
Key exclusion criteria (5 listed)
- Subject has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days, or herbal therapy within 7 days prior to the first dose of ABT-700.
- Subjects with uncontrolled metastases of the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease after definitive therapy and have not used steroids for at least 1 month prior to first dose of ABT-700.
- Subject has unresolved adverse events > Grade 1 from prior anticancer therapy except for alopecia or anemia.
- Subject has had major surgery within 21 days prior to the first dose of ABT-700.
- Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive docetaxel or FOLFIRI/cetuximab or erlotinib per most current prescribing information, or at the discretion of the Investigator. Subjects with K-Ras mutation-positive colorectal cancer will be excluded from receiving FOLFIRI/cetuximab.
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-700ABT-700 will be administered by intravenous infusion at escalating dose levels on day 1 in 21-day dosing cycles. Additional subjects will be enrolled in an dose expansion cohort that will further evaluate ABT-700. | Drug | Cohort A, Cohort B, Cohort C, Cohort D |
| docetaxelDocetaxel will be administered by intravenous infusion on Day 1 in 21-day dosing cycles. | Drug | Cohort B |
| FOLFIRI5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion on Day 1 and 15 in 28-day dosing cycles. | Drug | Cohort C |
| cetuximabCetuximab will be administered by intravenous infusion weekly. | Drug | Cohort C |
| erlotinibErlotinib will be taken orally daily. | Drug | Cohort D |
| ABT-700ABT-700 will be administered by intravenous infusion on Day 1 and Day 15 in 28-day dosing cycles. | Drug | Cohort C |
Primary outcome
To evaluate the safety and tolerability of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
Time frame: First cycle of treatment through 60 day follow-up visit
Evaluation of vital signs, clinical lab testing, physical exams and adverse event monitoring
To Evaluate the pharmacokinetics of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
Time frame: At each cycle of treatment through 60 days after last dose.
Pharmacokinetic profile of ABT-700 analyzed from blood samples
To determine the recommended Phase 2 dose for ABT-700
Time frame: First cycle of treatment through 60 day follow-up visit
1 secondary outcome
To evaluate the preliminary efficacy of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
Time frame: Screening through 60 day follow-up visit
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.
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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.
Louie Naumovski, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-700, docetaxel and FOLFIRI in people with Advanced Solid Tumors, run by AbbVie (prior sponsor, Abbott).
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 4 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.
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?
To evaluate the safety and tolerability of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib (time frame: First cycle of treatment through 60 day follow-up visit). 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?
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.