NCT02663518 · OUTCOME

Part 4: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621

A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors · Source last updated 2024-05-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: Nanogram*hour per milliliter
Interval / dispersion: Standard Deviation
Time frame: Part 4: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1

Analysis population: PK -evaluable set included treated participants with adequate blood sampling to estimate at least one PK parameter. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Groups in this outcome

Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg

Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.

Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg

Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.

Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg

Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.

Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg

Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.

Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg

Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.

Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg

Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.

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
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg	3
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg	3
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg	5
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg	2
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg	8
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg	0

Reported measurements

Source class 1

Values in Nanogram*hour per milliliter · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg	88800	12300	Not reported	Not reported	Not reported
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg	116000	38800	Not reported	Not reported	Not reported
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg	212000	85700	Not reported	Not reported	Not reported
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg	383000	49600	Not reported	Not reported	Not reported
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg	638000	120000	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
12300
value
88800
group Id
OG001
spread
38800
value
116000
group Id
OG002
spread
85700
value
212000
group Id
OG003
spread
49600
value
383000
group Id
OG004
spread
120000
value
638000

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
5
group Id
OG003
value
2
group Id
OG004
value
8
group Id
OG005
value
0
units
Participants

dispersion Type

Standard Deviation

groups

description
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
id
OG000
title
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
description
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
id
OG001
title
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
description
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
id
OG002
title
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
description
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
id
OG003
title
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
description
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
id
OG004
title
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
description
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
id
OG005
title
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg

param Type

MEAN

population Description

PK -evaluable set included treated participants with adequate blood sampling to estimate at least one PK parameter. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

reporting Status

POSTED

time Frame

Part 4: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1

title

Part 4: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621

type

SECONDARY

unit Of Measure

Nanogram*hour per milliliter

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice