Stopped: B2341002 was terminated on 26-OCT-2017 for strategic reasons. The decision to terminate the trial was not based on any safety concerns.
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).
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Number of Participants With Treatment-Emergent Thromboembolic and/or Ischemic Events (TIEs)
Timeframe: Day 1 through day of discharge (Day 8)
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Timeframe: Day 1 through follow-up visit (Day 43)
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Timeframe: Day 1 through day of discharge (Day 8)
Number of Participants With Treatment-Emergent Laboratory Abnormalities
Timeframe: Day 1 through Day 8 (or discharge) for D-dimer laboratory test and urinalysis; Day 1 through Day 4 for all other laboratory tests
Number of Participants With Changes From Baseline in Physical Examination
Timeframe: Baseline (pre-dose), Day 2, Day 3, Day 4, Day 8/discharge
Change From Baseline for Body Temperature
Timeframe: Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge
Change From Baseline for Supine Respiratory Rate
Timeframe: Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge
Change From Baseline for Supine Systolic and Diastolic Blood Pressure
Timeframe: Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge
Change From Baseline for Supine Pulse Rate
Timeframe: Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge
Number of Participants With Electrocardiogram (ECG) Qualitative Results
Timeframe: Baseline (pre-dose), Day 2, Day 4, Day 8/discharge