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NCT02663518 · OUTCOME

Part 4: Duration of Response (DoR)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)

What was measured

DoR was defined, in participants who achieved a response as time from the first date of response to the first date of recurrent or progression disease. Participants without recurrent or progression disease were censored on date of the last adequate disease assessment, date of initiation of anticancer treatment or death of death, whichever was the earliest.

Analysis population: Analysis population included all the participants who received at least one dose of study treatment. Here, "Number of Participants Analyzed" refers to 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

GroupSource count
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg0
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg0
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg1
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg1
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg2
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg0

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kgNANot reportedNANAMedian and 95% CI could not be estimated due to less number of participants with events.
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kgNANot reportedNANAMedian and 95% CI could not be estimated due to less number of participants with events.
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kgNANot reportedNANAMedian and 95% CI could not be estimated due to less number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and 95% CI could not be estimated due to less number of participants with events.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median and 95% CI could not be estimated due to less number of participants with events.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        Median and 95% CI could not be estimated due to less number of participants with events.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      2
    6. group Id
      OG005
      value
      0
    units
    Participants
description
DoR was defined, in participants who achieved a response as time from the first date of response to the first date of recurrent or progression disease. Participants without recurrent or progression disease were censored on date of the last adequate disease assessment, date of initiation of anticancer treatment or death of death, whichever was the earliest.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
MEDIAN
population Description
Analysis population included all the participants who received at least one dose of study treatment. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)
title
Part 4: Duration of Response (DoR)
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice