CancerPhase 1NCT01727869
Study of REGN1400 Alone and in Combination With Erlotinib or Cetuximab in Patients With Certain Types of Cancer
A Phase 1 study testing REGN1400, Erlotinib and Cetuximab in people with Cancer, run by Regeneron Pharmaceuticals at 6 sites in United States.
Trial summary
This is an open-label, multicenter, ascending multiple dose study of REGN1400 alone and in combination with erlotinib or cetuximab administered to patients with certain types of cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- REGN1400, Erlotinib and Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2012to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria include, but are not limited to, the following:
- Confirmed diagnosis of certain unresectable or metastatic cancers
- Adequate Eastern Cooperative Oncology Group (ECOG) performance status
- Adequate hepatic, renal and bone marrow function
- Resolution of toxicity from prior therapy to grade less than/ = to 1
Exclusion Criteria include, but are not limited to, the following:
- Active brain metastases
- Thromboembolic events < 6 months prior to study
- Patients with a recent history (within 5 years) of another malignancy.
- Investigational or any antitumor treatment with a maximum of 4 half-lives or administered 30 days prior to the initial administration of REGN1400
- Patients who are pregnant or nursing
- Prior treatment with ErbB3 inhibitors
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Atlanta, Georgia
Study site
Buffalo, New York
Study site
Detroit, Michigan
Study site
New York, New York
Study site
San Antonio, Texas
Study site
Santa Monica, California
About this study
This is an open-label, multicenter, ascending multiple dose study of REGN1400 alone and in combination with erlotinib or cetuximab administered to patients with certain types of cancer.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab Receives: Drug: REGN1400; Drug: Erlotinib; Drug: Cetuximab |
| Cohort 2 | Experimental | Dosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab Receives: Drug: REGN1400; Drug: Erlotinib; Drug: Cetuximab |
| Cohort 3 | Experimental | Dosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab Receives: Drug: REGN1400; Drug: Erlotinib; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to characterize the safety profile of REGN1400 alone and in combination with erlotinib or cetuximab
Safety will be assessed through analysis of laboratory data, physical examination findings and vital signs according to the schedule of assessments, in addition to the spontaneous reporting of adverse events according to CTCAE version 4.
Measured: Day 1 - Day 28
Secondary outcomes (1)
Recommended Phase 2 Dose (RP2D)
Determine a recommended phase 2 dose (RP2D) of REGN1400 in combination with erlotinib or cetuximab
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727869
- Sponsor's protocol ID
- R1400-ST-1113
- Status last verified
- Apr 2015
- First submitted
- 2 Nov 2012
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of REGN1400 Alone and in Combination With Erlotinib or Cetuximab in Patients With Certain Types of Cancer
- ClinicalTrials.gov ID
- NCT01727869
- Acronym / sponsor ID
- R1400-ST-1113
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Nov 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.
This is an open-label, multicenter, ascending multiple dose study of REGN1400 alone and in combination with erlotinib or cetuximab administered to patients with certain types of cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: REGN1400, Drug: Erlotinib, Drug: CetuximabDosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab |
| Cohort 2 | Experimental | Drug: REGN1400, Drug: Erlotinib, Drug: CetuximabDosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab |
| Cohort 3 | Experimental | Drug: REGN1400, Drug: Erlotinib, Drug: CetuximabDosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| REGN1400 | Drug | Cohort 1, Cohort 2, Cohort 3 |
| Erlotinib | Drug | Cohort 1, Cohort 2, Cohort 3 |
| Cetuximab | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
The primary objective of the study is to characterize the safety profile of REGN1400 alone and in combination with erlotinib or cetuximab
Time frame: Day 1 - Day 28
Safety will be assessed through analysis of laboratory data, physical examination findings and vital signs according to the schedule of assessments, in addition to the spontaneous reporting of adverse events according to CTCAE version 4.
1 secondary outcome
Recommended Phase 2 Dose (RP2D)
Time frame: Day 1 to Day 28
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 6 Apr 2015.
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
6 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 REGN1400, Erlotinib and Cetuximab in people with Cancer, run by Regeneron Pharmaceuticals at 6 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?
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 6 Apr 2015. 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. 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?
The primary objective of the study is to characterize the safety profile of REGN1400 alone and in combination with erlotinib or cetuximab (time frame: Day 1 - Day 28). 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 6 Apr 2015.