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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01273467
First received: January 7, 2011
Last updated: March 16, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Stroke
Ischemia
Infarction
Drug: CNTO 0007 or placebo (Stage A)
Drug: CNTO 0007 or placebo (Stage B)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • The number and type of adverse events reported [ Time Frame: Up to 90 days following study drug administration ] [ Designated as safety issue: No ]
  • Changes in clinical laboratory test values [ Time Frame: Up to 90 days following study drug administration ] [ Designated as safety issue: No ]
  • Changes in vital signs measurements [ Time Frame: Up to 90 days following study drug administration ] [ Designated as safety issue: No ]
  • Changes in electrocardiograms [ Time Frame: Up to 90 days following study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood concentration of CNTO 0007 [ Time Frame: At protocol-specified time points on Day 1 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: December 2010
Study Completion Date: July 2013
Arms Assigned Interventions
Experimental: 001
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: 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)
Experimental: 002
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: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273467

Locations
United States, Oregon
Portland, Oregon, United States
United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01273467     History of Changes
Other Study ID Numbers: CR016510, 42037788
Study First Received: January 7, 2011
Last Updated: March 16, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Janssen Research & Development, LLC:
Ischemic Cerebral Infarction
Stroke
CNTO0007
42037788

Additional relevant MeSH terms:
Cerebral Infarction
Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014