NCT05185947 · OUTCOME

Median Peritoneal Progression-free Survival (pPFS)

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: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: Baseline, at peritoneal disease relapse from Complete Response (CR) or peritoneal disease progression, and after completion of therapy, a median of 5.04 months

What was measured

Kaplan-Meier method will be used to evaluate peritoneal progression-free survival (pPFS). Median peritoneal progression-free survival (pPFS) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and will be reported along with a 95% two-sided confidence interval. Progressive Disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on available studies. The appearance of one or more new lesions is also considered progression.

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

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1	3.779	Not reported	3.751	3.779	Not reported
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1	3.3580	Not reported	3.3580	3.3580	Not reported
Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1	2.826	Not reported	2.826	2.826	Not reported
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1	10.218	Not reported	10.218	10.218	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
3.751
upper Limit
3.779
value
3.779
group Id
OG001
lower Limit
3.3580
upper Limit
3.3580
value
3.3580
group Id
OG002
lower Limit
2.826
upper Limit
2.826
value
2.826
group Id
OG003
lower Limit
10.218
upper Limit
10.218
value
10.218

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

dispersion Type

95% Confidence Interval

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

MEDIAN

population Description

7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment.

reporting Status

POSTED

time Frame

Baseline, at peritoneal disease relapse from Complete Response (CR) or peritoneal disease progression, and after completion of therapy, a median of 5.04 months

title

Median Peritoneal Progression-free Survival (pPFS)

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice