NCT05185947 · OUTCOME
Number of Grades 3, 4, and/or 5 Serious and/or Non-serious Toxicities by Type Assessed Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis · Source last updated 2026-06-25
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure NUMBER
Unit toxicities
Interval / dispersion Not reported
Time frame Day-4 through completion of surveillance post-treatment, up to 2 years. What was measured Safety will be assessed by analyzing the type, grade and frequency of toxicities. Adverse events (AEs) will be assessed using CTCAE v.5.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Analysis population: 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment.
Groups in this outcome Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m\^2 of intravenous (IV) Paclitaxel.
Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD).
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group Source count Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 4 Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 1 Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 1 Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 1
Reported measurements Grade 3 Serious - Sepsis Values in toxicities · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 1 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 0 Not reported Not reported Not reported Not reported
Grade 4 Serious - Peritoneal infection Values in toxicities · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 1 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 0 Not reported Not reported Not reported Not reported
Grade 3 Non-serious - Abdominal pain Values in toxicities · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 1 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 0 Not reported Not reported Not reported Not reported
Grade 3 Non-serious - Anemia Values in toxicities · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 1 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 6 Not reported Not reported Not reported Not reported
Grade 3 Non-serious - Atrial fibrillation Values in toxicities · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 1 Not reported Not reported Not reported Not reported
Grade 3 Non-serious - Diarrhea Values in toxicities · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 1 Not reported Not reported Not reported Not reported
Grade 3 Non-serious - Electrocardiogram QT corrected interval prolonged Values in toxicities · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 1 Not reported Not reported Not reported Not reported
Grade 3 Non-serious - Fatigue Values in toxicities · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 1 Not reported Not reported Not reported Not reported
Grade 3 Non-serious - Hypokalemia Values in toxicities · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 1 Not reported Not reported Not reported Not reported
Grade 3 Non-serious - Hypotension Values in toxicities · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 1 Not reported Not reported Not reported Not reported
Grade 3 Non-serious - Neutrophil count decreased Values in toxicities · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 1 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 1 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 1 Not reported Not reported Not reported Not reported
Grade 3 Non-serious - White blood cell decreased Values in toxicities · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 2 Not reported Not reported Not reported Not reported
Grade 4 Non-serious - Neutrophil count decreased Values in toxicities · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 2 Not reported Not reported Not reported Not reported
Grade 4 Non-serious - White blood cell decreased Values in toxicities · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 0 Not reported Not reported Not reported Not reported Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 1 Not reported Not reported Not reported Not reported
Complete source fields classes categories measurements
group Id OG000
value 1
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
title Grade 3 Serious - Sepsis categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 0
title Grade 4 Serious - Peritoneal infection categories measurements
group Id OG000
value 1
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
title Grade 3 Non-serious - Abdominal pain categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 6
title Grade 3 Non-serious - Anemia categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 1
title Grade 3 Non-serious - Atrial fibrillation categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 1
title Grade 3 Non-serious - Diarrhea categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 1
title Grade 3 Non-serious - Electrocardiogram QT corrected interval prolonged categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 1
title Grade 3 Non-serious - Fatigue categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 1
title Grade 3 Non-serious - Hypokalemia categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 1
title Grade 3 Non-serious - Hypotension categories measurements
group Id OG000
value 0
group Id OG001
value 1
group Id OG002
value 1
group Id OG003
value 1
title Grade 3 Non-serious - Neutrophil count decreased categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 2
title Grade 3 Non-serious - White blood cell decreased Show more (12 of 14) denoms counts
group Id OG000
value 4
group Id OG001
value 1
group Id OG002
value 1
group Id OG003
value 1
units Participants
description Safety will be assessed by analyzing the type, grade and frequency of toxicities. Adverse events (AEs) will be assessed using CTCAE v.5.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. groups
description Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).
id OG000
title Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
description Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m\^2 of intravenous (IV) Paclitaxel.
id OG001
title Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
description Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).
id OG002
title Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1
description Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD).
id OG003
title Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1
param Type NUMBER
population Description 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment.
reporting Status POSTED
time Frame Day-4 through completion of surveillance post-treatment, up to 2 years.
title Number of Grades 3, 4, and/or 5 Serious and/or Non-serious Toxicities by Type Assessed Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
type SECONDARY
unit Of Measure toxicities Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle