Demographics
Inclusion Criteria Inclusion Criteria
Exclusion Criteria Exclusion Criteria
Screening Medical History Screening Medical History
Screening Vital Signs And Physical Exam (within 21 Days of Dose 1) Screening Vital Signs And Physical Exam (within 21 Days of Dose 1)
Screening Laboratory Measures (within 21 Days prior to Dose 1) Screening Laboratory Measures (within 21 Days prior to Dose 1)
Screening Hematology and Pregnancy Test(within 21 Days prior to Dose 1) Screening Hematology and Pregnancy Test(within 21 Days prior to Dose 1)
Screening Chemistry (within 21 Days prior to Dose 1) Screening Chemistry (within 21 Days prior to Dose 1)
Screening Urinalysis and Toxicology (within 21 Days prior to Dose 1) Screening Urinalysis and Toxicology (within 21 Days prior to Dose 1)
Screening Histologically Confirmed Solid Tumor Screening Histologically Confirmed Solid Tumor
Screening Liver Function Tests Screening Liver Function Tests
Screening ECOG Performance Status Screening ECOG Performance Status
Screening ECG Screening ECG
Baseline Vital Signs and Physical Exam (within 72 hrs of Dose 1) Baseline Vital Signs and Physical Exam (within 72 hrs of Dose 1)
Baseline Laboratory Measures (within 72 hrs prior to Dose 1) Baseline Laboratory Measures (within 72 hrs prior to Dose 1)
Baseline Hematology and Pregnancy Test (within 72 hrs prior to Dose 1) Baseline Hematology and Pregnancy Test (within 72 hrs prior to Dose 1)
Baseline Chemistry (within 72 hrs prior to Dose 1) Baseline Chemistry (within 72 hrs prior to Dose 1)
Baseline Urinalysis and Toxicology (within 72 hrs prior to Dose 1) Baseline Urinalysis and Toxicology (within 72 hrs prior to Dose 1)
Baseline Liver Function Tests Baseline Liver Function Tests
Baseline ECOG Performance Status Baseline ECOG Performance Status
Baseline Tumor Assessment by Standard Method (MRI,CT, etc) (30 days prior to initial treatment) Baseline Tumor Assessment by Standard Method (MRI,CT, etc) (30 days prior to initial treatment)
28 Day Cycle, Cycle 1, Day 1 28 Day Cycle, Cycle 1, Day 1
ECG: 28 Day Cycle 1 Dosing Day 1 ECG: 28 Day Cycle 1 Dosing Day 1
28 Days Cycle #, Week #, Study Day # Vital Signs and Physical Exam 28 Days Cycle #, Week #, Study Day # Vital Signs and Physical Exam
28 Days Cycle #, Treatment Week #, Study Day # Laboratory Measures 28 Days Cycle #, Treatment Week #, Study Day # Laboratory Measures
28 Days Cycle #, Treatment Week #, Study Day # Hematology and Pregnancy Test 28 Days Cycle #, Treatment Week #, Study Day # Hematology and Pregnancy Test
28 Days Cycle #, Treatment Week #, Study Day # Chemistry 28 Days Cycle #, Treatment Week #, Study Day # Chemistry
28 Days Cycle #, Day # Urinalysis 28 Days Cycle #, Day # Urinalysis
28 Days Cycle #, Treatment Week #, Dosing Day # Urinalysis 28 Days Cycle #, Treatment Week #, Dosing Day # Urinalysis
28 Days Cycle #, Week #, Day # ECOG Performance Status 28 Days Cycle #, Week #, Day # ECOG Performance Status
28 Days Cycle #, Treatment Week #, Study Day # Vital Signs and Targeted Physical Exam 28 Days Cycle #, Treatment Week #, Study Day # Vital Signs and Targeted Physical Exam
28 Days Cycle #, Day # Vital Signs and AE Query 28 Days Cycle #, Day # Vital Signs and AE Query
ECG: 28 Day Cycle 1 Dosing Day 26 ECG: 28 Day Cycle 1 Dosing Day 26
28 Days Cycle #1 PK Sampling Record During First Month of Each Cohort Only 28 Days Cycle #1 PK Sampling Record During First Month of Each Cohort Only
28 Days Cycle # PD Sampling Record; Sampling Day 1 of each Cycle 28 Days Cycle # PD Sampling Record; Sampling Day 1 of each Cycle
28 Day Cycle #, Tumor Assessment by Standard Method (MRI, CT, etc) 28 Day Cycle #, Tumor Assessment by Standard Method (MRI, CT, etc)
28 Days Cycle # Dosing Record 28 Days Cycle # Dosing Record
Prior and Concomitant Medications Prior and Concomitant Medications
Abnormal Laboratories Abnormal Laboratories
Adverse Events Adverse Events
Unscheduled Laboratory Measures Unscheduled Laboratory Measures
28 Day Cycle #, Day # ECG 28 Day Cycle #, Day # ECG
Follow Up Vital Signs and Physical Exam Follow Up Vital Signs and Physical Exam
28 Days Cycle #, Treatment Week Number #, Study Day # Interval History 28 Days Cycle #, Treatment Week Number #, Study Day # Interval History
28 Days Cycle #, Treatment Week Number #, Study Day # Laboratory Measures 28 Days Cycle #, Treatment Week Number #, Study Day # Laboratory Measures
Discharge Vital Signs and Physical Exam Baseline: ECOG Performance Status
Discharge Laboratory Measures Discharge Laboratory Measures
Discharge Hematology Discharge Hematology
At the MTD Pre Dose Liver Function Tests At the MTD Pre Dose Liver Function Tests
At the MTD 24hr post dosing Liver Function Tests At the MTD 24hr post dosing Liver Function Tests
At the MTD Liver Function Tests 28 Day Cycle#, Tumor Assessment by Standard Method (MRI, CT, etc)
28 Day Cycle 1 MTD Only: Day 1 and Day 26 Urine Collection for PK Analysis 28 Day Cycle 1 MTD Only: Day 1 and Day 26 Urine Collection for PK Analysis
At the MTD Urinalysis At the MTD Urinalysis
At the MTD Chemistry At the MTD Chemistry
At the MTD Pre Dose Hematology Test At the MTD Pre Dose Hematology Test
Assessment of Tumor Vascularity by DCE-MRI 24 hrs Pre-Dose Assessment of Tumor Vascularity by DCE-MRI 24 hrs Pre-Dose
Assessment of Tumor Vascularity by DCE-MRI 24 hrs Post-Dose Assessment of Tumor Vascularity by DCE-MRI 24 hrs Post-Dose
Study Exit Liver Function Tests Study Exit Liver Function Tests
Study Exit, Study Day # Vital Signs and Physical Examination Study Exit, Study Day # Vital Signs and Physical Examination
Study Exit, Study Day # Laboratory Measures Study Exit, Study Day # Laboratory Measures
Study Exit, Study Day # Chemistry Study Exit, Study Day # Chemistry
Study Exit, Study Day # Urinalysis and Toxicology Study Exit, Study Day # Urinalysis and Toxicology
Study Termination Study Termination
End Study ECG End Study - ECG
End of Treatment Follow Up Period (Contact subject every 2-3 Mo for 6 Months) End of Treatment Follow Up Period (Contact subject every 2-3 Mo for 6 Months)