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Trial record 1 of 1 for:    B2341002
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Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02687191
First received: February 16, 2016
Last updated: June 6, 2017
Last verified: June 2017
  Purpose

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 Intervention Phase
Intracerebral Hemorrhage (ICH) Biological: PF-05230907 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

  • Physical examination changes [ Time Frame: Day 1 through Day 8 ]
  • Vital sign changes [ Time Frame: Day 1 through Day 8 ]
  • Electrocardiogram (ECG) results [ Time Frame: Day 1 through Day 8 ]

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

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

Estimated Enrollment: 51
Actual Study Start Date: November 26, 2016
Estimated Study Completion Date: June 18, 2018
Estimated Primary Completion Date: June 18, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
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
  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: NCT02687191

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 35 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02687191     History of Changes
Other Study ID Numbers: B2341002
2015-005703-83 ( EudraCT Number )
Study First Received: February 16, 2016
Last Updated: June 6, 2017

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

ClinicalTrials.gov processed this record on June 28, 2017