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Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage

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ClinicalTrials.gov Identifier: NCT02687191
Recruitment Status : Terminated (B2341002 was terminated on 26-OCT-2017 for strategic reasons. The decision to terminate the trial was not based on any safety concerns.)
First Posted : February 22, 2016
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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).


Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Biological: PF-05230907 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 26, 2016
Actual Primary Completion Date : January 15, 2018
Actual Study Completion Date : January 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: PF-05230907 (Cohort 1)
PF-05230907 IV bolus injection
Biological: PF-05230907
PF-05230907 IV bolus injection

Experimental: PF-05230907 (Cohort 2)
PF-05230907 IV bolus injection
Biological: PF-05230907
PF-05230907 IV bolus injection

Experimental: PF-05230907 (Cohort 3)
PF-05230907 IV bolus injection
Biological: PF-05230907
PF-05230907 IV bolus injection

Experimental: PF-05230907 (Cohort 4)
PF-05230907 IV bolus injection
Biological: PF-05230907
PF-05230907 IV bolus injection

Experimental: PF-05230907 (Cohort 5)
PF-05230907 IV bolus injection
Biological: PF-05230907
PF-05230907 IV bolus injection

Experimental: PF-05230907 (Cohort 6)
PF-05230907 IV bolus injection
Biological: PF-05230907
PF-05230907 IV bolus injection

Experimental: PF-05230907 (Cohort 7)
PF-05230907 IV bolus injection
Biological: PF-05230907
PF-05230907 IV bolus injection

Experimental: PF-05230907 (Cohort 8)
PF-05230907 IV bolus injection
Biological: PF-05230907
PF-05230907 IV bolus injection

Experimental: PF-05230907 (Cohort 9)
PF-05230907 IV bolus injection
Biological: PF-05230907
PF-05230907 IV bolus injection

Experimental: PF-05230907 (Cohort 10)
PF-05230907 IV bolus injection
Biological: PF-05230907
PF-05230907 IV bolus injection

Experimental: PF-05230907 (Cohort 11)
PF-05230907 IV bolus injection
Biological: PF-05230907
PF-05230907 IV bolus injection

Experimental: PF-05230907 (Cohort 12)
PF-05230907 IV bolus injection
Biological: PF-05230907
PF-05230907 IV bolus injection

Experimental: PF-05230907 (Cohort 13)
PF-05230907 IV bolus injection
Biological: PF-05230907
PF-05230907 IV bolus injection

Experimental: PF-05230907 (Cohort 14)
PF-05230907 IV bolus injection
Biological: PF-05230907
PF-05230907 IV bolus injection

Experimental: PF-05230907 (Cohort 15)
PF-05230907 IV bolus injection
Biological: PF-05230907
PF-05230907 IV bolus injection




Primary Outcome Measures :
  1. Frequency of treatment emergent thromboembolic and/or ischemic events (TIEs) [ Time Frame: Day 1 through Day 8 ]
  2. Frequency of treatment emergent serious adverse events (SAEs) [ Time Frame: Day 1 through Day 43 ]
  3. Frequency of treatment emergent adverse events (AEs) [ Time Frame: Day 1 through Day 8 ]
  4. Frequency of treatment emergent laboratory abnormalities [ Time Frame: Day 1 through Day 4 ]
    Day 1 through Day 8 for D-dimer labs

  5. Physical examination changes [ Time Frame: Day 1 through Day 8 ]
  6. Vital sign changes [ Time Frame: Day 1 through Day 8 ]
  7. Electrocardiogram (ECG) results [ Time Frame: Day 1 through Day 8 ]

Secondary Outcome Measures :
  1. Changes in aPTT [ Time Frame: Day 1 through Day 2 ]
  2. Changes in PF 1+2 [ Time Frame: Day 1 through Day 2 ]
  3. Frequency of anti-drug and/or neutralizing antibody production [ Time Frame: Day 1 through Day 91 ]
  4. Factor X activity [ Time Frame: Day 1 through Day 91 ]

Other Outcome Measures:
  1. Change in ICH volume from baseline volume at 24 hours [ Time Frame: Day 1 to Day 2 ]
  2. PF-05230907 concentration in plasma [ Time Frame: Day 1 ]
  3. Frequency of anti-Chinese hamster ovary (CHO) protein antibody production [ Time Frame: Day 1 to Day 43 ]
  4. Frequency of anti-paired basic amino acid cleaving enzyme (PACE) furin antibody production [ Time Frame: Day 1 to Day 43 ]
  5. Neurological function as assessed by the NIH Stroke Scale [ Time Frame: Day 1 through Day 91 ]
  6. Health resource utilization [ Time Frame: Day 8 through Day 91 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687191


Locations
United States, Missouri
Barnes Jewish Hospital
Saint Louis, Missouri, United States, 63110
Washington University,
Saint Louis, Missouri, United States, 63110
United States, Ohio
James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Martha Morehouse Medical Plaza
Columbus, Ohio, United States, 43221
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y4E9
Canada, Quebec
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada, H3A2B4
Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Clínico Universitario de Santiago de Compostela, Area Neurovascular-Neurologia
Santiago de Compostela, LA Coruna, Spain, 15706
Hospital Vall d'Hebron, Unidad de Ictus
Barcelona, Spain, 08035
Hospital Universitari Dr. Josep Trueta IDIBGI, Department Neurology
Girona, Spain, 17007
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
United Kingdom
University College Hospital
London, United Kingdom, NW1 2BU
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02687191     History of Changes
Other Study ID Numbers: B2341002
2015-005703-83 ( EudraCT Number )
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
safety, maximum tolerated dose, modified continual reassessment method, intracerebral, hemorrhage, hematoma

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases