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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.
Verified November 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT02687191
First Posted: February 22, 2016
Last Update Posted: November 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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 Biological: PF-05230907 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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)

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: 36
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 38 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 )
First Submitted: February 16, 2016
First Posted: February 22, 2016
Last Update Posted: November 22, 2017
Last Verified: November 2017

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