Advanced Solid MalignanciesPhase 1NCT00871559
A Multiple-Ascending-Dose Study of the Safety and Tolerability of REGN421(SAR153192) in Patients With Advanced Solid Malignancies
A Phase 1 study testing REGN421(SAR153192) in people with Advanced Solid Malignancies, run by Regeneron Pharmaceuticals at 8 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of REGN421 (SAR153192) in patients with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Malignancies
- What is being tested?
- REGN421(SAR153192)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2009to Feb 2014
- 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
Who may be able to join
- Male or female 18 years of age or older
- Histologically diagnosis of advanced solid malignancy, with no standard therapeutic options of proven benefit.
- Patients with measurable or non-measurable disease
- At least 6 weeks must have elapsed since the last dose of bevacizumab (AvastinTM)
- At least 4 weeks must have elapsed since the last major surgery
- For women of childbearing potential, a negative urine pregnancy test at the screening visit
Show all 9Show fewer
- Willingness to use adequate contraception during the full course of the study. Systemic hormonal contraceptive agents are excluded
- Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
- Able to read, understand and willing to sign the informed consent form
Who cannot join
- Medical history of myocardial infarction or cardiomyopathy
- Unstable angina
- NYHA class II - IV congestive heart failure
- Patients under treatment with more than 2 antihypertensive medications
- History of bleeding peptic ulcer disease, erosive gastritis, intestinal perforation, or clinically significant GI hemorrhage within 6 months of study drug administration
- Diabetic retinopathy
- Patients requiring anticoagulation
- Hypersensitivity to doxycycline or related compounds
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Aurora, Colorado
Study site
Boston, Massachusetts
Study site
Columbus, Ohio
Study site
Detroit, Michigan
Study site
Indianapolis, Indiana
Study site
New York, New York
Study site
Oklahoma City, Oklahoma
Study site
St Louis, Missouri
About this study
Official title: A Phase 1, Multiple-Dose Study of the Safety and Tolerability of Single Agent REGN421 Administered Every 2 or 3 Weeks in Patients With Advanced Solid Malignancies
The purpose of this study is to assess the safety and tolerability of REGN421 (SAR153192) in patients with advanced solid malignancies.
- Conditions
- Advanced Solid Malignancies
- Being tested
- REGN421(SAR153192)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN421(SAR153192)Drug
| Study group | Role | What they receive |
|---|---|---|
| Q2W | Experimental | REGN421 (SAR153192) taken once every two weeks (Q2W) Receives: Drug: REGN421(SAR153192) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Measured: 18 months
Secondary outcomes (1)
Preliminary evidence of antitumor activity
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid MalignanciesStudies 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871559
- Sponsor's protocol ID
- R421-ST-0804
- Status last verified
- Mar 2014
- First submitted
- 25 Mar 2009
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multiple-Dose Study of the Safety and Tolerability of Single Agent REGN421 Administered Every 2 or 3 Weeks in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00871559
- Acronym / sponsor ID
- R421-ST-0804
- Conditions
- Advanced Solid Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Jun 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 Mar 2009 (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.
The purpose of this study is to assess the safety and tolerability of REGN421 (SAR153192) in patients with advanced solid malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Q2W | Experimental | Drug: REGN421(SAR153192)REGN421 (SAR153192) taken once every two weeks (Q2W) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female 18 years of age or older
- Histologically diagnosis of advanced solid malignancy, with no standard therapeutic options of proven benefit.
- Patients with measurable or non-measurable disease
- At least 6 weeks must have elapsed since the last dose of bevacizumab (AvastinTM)
- At least 4 weeks must have elapsed since the last major surgery
Key exclusion criteria (8 listed)
- Medical history of myocardial infarction or cardiomyopathy
- Unstable angina
- NYHA class II - IV congestive heart failure
- Patients under treatment with more than 2 antihypertensive medications
- History of bleeding peptic ulcer disease, erosive gastritis, intestinal perforation, or clinically significant GI hemorrhage within 6 months of study drug administration
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 |
|---|---|---|
| REGN421(SAR153192) | Drug | Q2W |
Primary outcome
Safety and tolerability
Time frame: 18 months
1 secondary outcome
Preliminary evidence of antitumor activity
Time frame: 18 months
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 26 Mar 2014.
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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
8 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 REGN421(SAR153192) in people with Advanced Solid Malignancies, run by Regeneron Pharmaceuticals at 8 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 9 inclusion and 8 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 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 and tolerability (time frame: 18 months). 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 26 Mar 2014.