StrokePhase 1NCT01273467
A Safety and Tolerability Study of 42037788 (Referred to as CNTO 0007) Compared With Placebo in Patients Who Have Experienced Ischemic Cerebral Infarction (Also Known as Stroke)
A Phase 1 study of Stroke and Ischemia, run by Janssen Research & Development, LLC at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of 42037788 (CNTO 0007) in patients who have suffered a stroke. The study is not designed to establish efficacy, although preliminary explorations will be conducted. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Ischemia, Infarction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2010to Jul 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who have suffered an ischemic stroke, as defined by the protocol (If a woman, must be postmenopausal, defined as having no menses for the 18 months before study start. Premenopausal, surgically-sterilized women must have a negative serum beta human chorionic gonadotropin pregnancy test at screening before CNTO 0007 or placebo administration)
- Patients must be able to remain as inpatients for at least 3 days post-infusion for intensive safety monitoring
- Patients must receive standard post-stroke care before the infusion begins and after treatment with experimental product, including but not limited to appropriate secondary prevention measure such as blood pressure and cholesterol control and antiplatelet agents, unless contraindicated
- Patient must have no clinical evidence of worsening stroke in the last 24 hours prior to the start of the infusion of study treatment
- Patients must have general medical condition consistent with expected survival for at least 1 year.
Who cannot join
- Presence or history of any clinically significant disease, medical condition, or treatment intervention as determined by the Investigator
- Need for supplementary oxygen for cardiorespiratory reasons or respirator dependency. If supplementary oxygen is not needed for cardiopulmonary reasons but given on a routine basis, it is not exclusionary
- Presence or history of alcohol or drug abuse as defined by the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) within 1 year before the screening phase.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Houston, Texas
Study site
Portland, Oregon
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Ascending Single-Dose Study of the Intravenous Infusion of CNTO 0007 in Subjects Who Have Experienced Ischemic Cerebral Infarction
The purpose of this study is to evaluate the safety and tolerability of 42037788 (CNTO 0007) in patients who have suffered a stroke. The study is not designed to establish efficacy, although preliminary explorations will be conducted.
Read the detailed description
This is a first-in-human (FIH) study of 42037788 (referred to as CNTO 0007), a cell therapy being tested to see if it may be useful in treating patients with ischemic cerebral infarction also known as stroke. Patients will be randomized (assigned by chance) to receive a single dose of CNTO 0007 or placebo (identical in appearance to CNTO 0007 but does not contain cells) by intravenous (IV) infusion (injection directly into a vein). Patients and study staff will not know if patients are assigned CNTO 0007 or the placebo. The study will be conducted in 2 stages (Stage A and Stage B). In Stage A, the highest dose of CNTO 0007 that does not cause unacceptable side effects, referred to as the maximum tolerated dose (MTD) will be determined to and administered to patients in Stage B of the study. In Stage A, 5 (up to 7) cohorts (groups) of 4-8 patients each will be administered a single IV infusion of CNTO 0007 or placebo 1-5 days (depending on cohort) after stroke (the first cohort of patients will receive the lowest dose of CNTO 0007 or placebo and each subsequent cohort will be administered a higher dose of CNTO 0007 or placebo until the MTD is determined). In Stage B, patients will be administered a single IV infusion of the MTD within a specified number of days after stroke.
- Conditions
- Stroke, Ischemia, Infarction
- Being tested
- CNTO 0007 or placebo (Stage A), CNTO 0007 or placebo (Stage B)
- Keywords
- Ischemic Cerebral Infarction, Stroke, CNTO0007, 42037788
- Medical subject headings
- Stroke, Ischemia, Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTO 0007 or placebo (Stage A)Drug
a single IV infusion of a selected dose of CNTO 0007 or placebo administered IV within 1-5 days (depending on cohort) after stroke (first cohort of patients will receive the lowest dose of CNTO 0007 or placebo and each subsequent group will be administered a higher dose (to be determined)
CNTO 0007 or placebo (Stage B)Drug
a single IV infusion of the MTD of CNTO 0007 or placebo administered IV within a specified number of days after stroke
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | CNTO 0007 or placebo (Stage A) a single IV infusion of a selected dose of CNTO 0007 or placebo administered IV within 1-5 days (depending on cohort) after stroke (first cohort of patients will receive the lowest dose of CNTO 0007 or placebo and each subsequent group will be administered a higher dose (to be determined) Receives: Drug: CNTO 0007 or placebo (Stage A) |
| 002 | Experimental | CNTO 0007 or placebo (Stage B) a single IV infusion of the MTD of CNTO 0007 or placebo administered IV within a specified number of days after stroke Receives: Drug: CNTO 0007 or placebo (Stage B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and type of adverse events reported
Measured: Up to 90 days following study drug administration
Changes in clinical laboratory test values
Measured: Up to 90 days following study drug administration
Changes in vital signs measurements
Measured: Up to 90 days following study drug administration
Changes in electrocardiograms
Measured: Up to 90 days following study drug administration
Secondary outcomes (1)
Blood concentration of CNTO 0007
Measured: At protocol-specified time points on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startDec 2010
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC C. Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273467
- Sponsor's protocol ID
- CR016510
- Other IDs
- 42037788
- Status last verified
- Mar 2014
- First submitted
- 7 Jan 2011
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Ascending Single-Dose Study of the Intravenous Infusion of CNTO 0007 in Subjects Who Have Experienced Ischemic Cerebral Infarction
- ClinicalTrials.gov ID
- NCT01273467
- Acronym / sponsor ID
- CR016510
- Conditions
- Stroke, Ischemia, Infarction
- Keywords
- Ischemic Cerebral Infarction, Stroke, CNTO0007, 42037788
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Jan 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.
The purpose of this study is to evaluate the safety and tolerability of 42037788 (CNTO 0007) in patients who have suffered a stroke. The study is not designed to establish efficacy, although preliminary explorations will be conducted.
Detailed description
This is a first-in-human (FIH) study of 42037788 (referred to as CNTO 0007), a cell therapy being tested to see if it may be useful in treating patients with ischemic cerebral infarction also known as stroke. Patients will be randomized (assigned by chance) to receive a single dose of CNTO 0007 or placebo (identical in appearance to CNTO 0007 but does not contain cells) by intravenous (IV) infusion (injection directly into a vein). Patients and study staff will not know if patients are assigned CNTO 0007 or the placebo. The study will be conducted in 2 stages (Stage A and Stage B). In Stage A, the highest dose of CNTO 0007 that does not cause unacceptable side effects, referred to as the maximum tolerated dose (MTD) will be determined to and administered to patients in Stage B of the study. In Stage A, 5 (up to 7) cohorts (groups) of 4-8 patients each will be administered a single IV infusion of CNTO 0007 or placebo 1-5 days (depending on cohort) after stroke (the first cohort of patients will receive the lowest dose of CNTO 0007 or placebo and each subsequent cohort will be administered a higher dose of CNTO 0007 or placebo until the MTD is determined). In Stage B, patients will be administered a single IV infusion of the MTD within a specified number of days after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: CNTO 0007 or placebo (Stage A)CNTO 0007 or placebo (Stage A) a single IV infusion of a selected dose of CNTO 0007 or placebo administered IV within 1-5 days (depending on cohort) after stroke (first cohort of patients will receive the lowest dose of CNTO 0007 or placebo and each subsequent group will be administered a higher dose (to be determined) |
| 002 | Experimental | Drug: CNTO 0007 or placebo (Stage B)CNTO 0007 or placebo (Stage B) a single IV infusion of the MTD of CNTO 0007 or placebo administered IV within a specified number of days after stroke |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients who have suffered an ischemic stroke, as defined by the protocol (If a woman, must be postmenopausal, defined as having no menses for the 18 months before study start. Premenopausal, surgically-sterilized women must have a negative serum beta human chorionic gonadotropin pregnancy test at screening before CNTO 0007 or placebo administration)
- Patients must be able to remain as inpatients for at least 3 days post-infusion for intensive safety monitoring
- Patients must receive standard post-stroke care before the infusion begins and after treatment with experimental product, including but not limited to appropriate secondary prevention measure such as blood pressure and cholesterol control and antiplatelet agents, unless contraindicated
- Patient must have no clinical evidence of worsening stroke in the last 24 hours prior to the start of the infusion of study treatment
- Patients must have general medical condition consistent with expected survival for at least 1 year.
Key exclusion criteria (3 listed)
- Presence or history of any clinically significant disease, medical condition, or treatment intervention as determined by the Investigator
- Need for supplementary oxygen for cardiorespiratory reasons or respirator dependency. If supplementary oxygen is not needed for cardiopulmonary reasons but given on a routine basis, it is not exclusionary
- Presence or history of alcohol or drug abuse as defined by the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) within 1 year before the screening phase.
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 |
|---|---|---|
| CNTO 0007 or placebo (Stage A)a single IV infusion of a selected dose of CNTO 0007 or placebo administered IV within 1-5 days (depending on cohort) after stroke (first cohort of patients will receive the lowest dose of CNTO 0007 or placebo and each subsequent group will be administered a higher dose (to be determined) | Drug | 001 |
| CNTO 0007 or placebo (Stage B)a single IV infusion of the MTD of CNTO 0007 or placebo administered IV within a specified number of days after stroke | Drug | 002 |
Primary outcome
The number and type of adverse events reported
Time frame: Up to 90 days following study drug administration
Changes in clinical laboratory test values
Time frame: Up to 90 days following study drug administration
Changes in vital signs measurements
Time frame: Up to 90 days following study drug administration
Changes in electrocardiograms
Time frame: Up to 90 days following study drug administration
1 secondary outcome
Blood concentration of CNTO 0007
Time frame: At protocol-specified time points on Day 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 18 Mar 2014.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Janssen Research & Development, LLC C. Clinical Trial study director
Janssen Research & Development, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Stroke and Ischemia, run by Janssen Research & Development, LLC at 2 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 3 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 18 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 2 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 number and type of adverse events reported (time frame: Up to 90 days following study drug administration). The study lists 4 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 18 Mar 2014.