Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage

Pfizer

Status and phase

Terminated

Phase 1

Conditions

Intracerebral Hemorrhage

Treatments

Biological: PF-05230907

Study type

Interventional

Funder types

Industry

Identifiers

NCT02687191

B2341002

2015-005703-83 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

21 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

21 participants in 15 patient groups

PF-05230907 (Cohort 1)

Experimental group

Description: