Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage

NCT02687191

Last updated date
Study Location
Barnes Jewish Hospital
Saint Louis, Missouri, 63110, United States
Contact
1-800-718-1021

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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 < 60 mL

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


- 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

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Intracerebral HemorrhageSafety and Tolerability of PF-05230907 in Intracerebral Hemorrhage
NCT02687191
  1. Saint Louis, Missouri
  2. Saint Louis, Missouri
  3. Columbus, Ohio
  4. Columbus, Ohio
  5. Columbus, Ohio
  6. Ottawa, Ontario
  7. Montreal, Quebec
  8. Badalona, Barcelona
  9. Santiago de Compostela, LA Coruna
  10. Barcelona,
  11. Girona,
  12. Madrid,
  13. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage
Official Title  ICMJE 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)
Brief Summary

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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intracerebral Hemorrhage
Intervention  ICMJE Biological: PF-05230907
PF-05230907 IV bolus injection
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 15, 2017)
21
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2016)
50
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Spain,   United Kingdom,   United States
Removed Location Countries Germany,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT02687191
Other Study ID Numbers  ICMJE B2341002
2015-005703-83 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP