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Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage

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NCT02687191

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
Barnes Jewish Hospital
Saint Louis, Missouri, 63110 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Intracerebral Hemorrhage
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-79 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- ICH as documented by CT scan within 6.0 hours of symptom onset

- Baseline ICH volume > 5mL and

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Deep coma (Glasgow Coma Scale

- Modified Rankin Score > 3 prior to ICH onset

- Known history of schemic, vaso-occlusive or thrombotic events within 6 months prior to
screening

- Known prothrombotic disorders

- Known secondary ICH related to aneurysm, arteriovenous malformation, subarachnoid
hemorrhage, trauma, or other causes. CT angiography, MR, or other diagnostic studies
obtained as part of the standard of care may be used to assess eligibility.

- Known use of oral anticoagulant(s)

- Known use of low-molecular weight heparin or heparin

NCT02687191
Pfizer
Terminated
Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage

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Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage
A Phase 1b Multicenter, Open-label Study To Evaluate The Safety And Tolerability And Determine The Maximum Tolerated Dose Of Pf-05230907 In Subjects With Intracerebral Hemorrhage (Ich)

This study employs a modified continual reassessment method (mCRM) design to estimate the maximum tolerated dose (MTD) of PF-05230907, defined as a target toxicity rate of 15% based on treatment emergent thromboembolic and/or ischemic events (TIEs). The mCRM design utilizes Bayesian methodology to continuously learn the dose-toxicity relationship, which is characterized by a parametric model.

Subjects with a diagnosis of ICH (determined by computed tomography) will be enrolled in cohorts of 3. The total length of time planned for study participation is approximately 3 months; 6.0 hours for screening, a single dose administration with a 4-day minimum hospital confinement period and follow-up visits through Day 91.

Severity of adverse events (AEs) and serious adverse events (SAEs) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. All subjects who receive PF-05230907 are evaluable for TIEs. The determination of MTD using mCRM modeling will be based on TIEs which occur through 7 days post-dose (Day 8).
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Intracerebral Hemorrhage
Biological: PF-05230907
PF-05230907 IV bolus injection
  • Experimental: PF-05230907 (Cohort 1)
    PF-05230907 IV bolus injection
    Intervention: Biological: PF-05230907
  • Experimental: PF-05230907 (Cohort 2)
    PF-05230907 IV bolus injection
    Intervention: Biological: PF-05230907
  • Experimental: PF-05230907 (Cohort 3)
    PF-05230907 IV bolus injection
    Intervention: Biological: PF-05230907
  • Experimental: PF-05230907 (Cohort 4)
    PF-05230907 IV bolus injection
    Intervention: Biological: PF-05230907
  • Experimental: PF-05230907 (Cohort 5)
    PF-05230907 IV bolus injection
    Intervention: Biological: PF-05230907
  • Experimental: PF-05230907 (Cohort 6)
    PF-05230907 IV bolus injection
    Intervention: Biological: PF-05230907
  • Experimental: PF-05230907 (Cohort 7)
    PF-05230907 IV bolus injection
    Intervention: Biological: PF-05230907
  • Experimental: PF-05230907 (Cohort 8)
    PF-05230907 IV bolus injection
    Intervention: Biological: PF-05230907
  • Experimental: PF-05230907 (Cohort 9)
    PF-05230907 IV bolus injection
    Intervention: Biological: PF-05230907
  • Experimental: PF-05230907 (Cohort 10)
    PF-05230907 IV bolus injection
    Intervention: Biological: PF-05230907
  • Experimental: PF-05230907 (Cohort 11)
    PF-05230907 IV bolus injection
    Intervention: Biological: PF-05230907
  • Experimental: PF-05230907 (Cohort 12)
    PF-05230907 IV bolus injection
    Intervention: Biological: PF-05230907
  • Experimental: PF-05230907 (Cohort 13)
    PF-05230907 IV bolus injection
    Intervention: Biological: PF-05230907
  • Experimental: PF-05230907 (Cohort 14)
    PF-05230907 IV bolus injection
    Intervention: Biological: PF-05230907
  • Experimental: PF-05230907 (Cohort 15)
    PF-05230907 IV bolus injection
    Intervention: Biological: PF-05230907
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
June 18, 2018
June 18, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ICH as documented by CT scan within 6.0 hours of symptom onset
  • Baseline ICH volume > 5mL and < 60 mL

Exclusion Criteria:

  • Deep coma (Glasgow Coma Scale < 6)
  • Modified Rankin Score > 3 prior to ICH onset
  • Known history of schemic, vaso-occlusive or thrombotic events within 6 months prior to screening
  • Known prothrombotic disorders
  • Known secondary ICH related to aneurysm, arteriovenous malformation, subarachnoid hemorrhage, trauma, or other causes. CT angiography, MR, or other diagnostic studies obtained as part of the standard of care may be used to assess eligibility.
  • Known use of oral anticoagulant(s)
  • Known use of low-molecular weight heparin or heparin
Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Canada,   Germany,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT02687191
B2341002
2015-005703-83 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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