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NCT04628780 · OUTCOME

Time to Progression (TTP) in Participants With Progressive Disease Based on Investigator Assessment

Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors · Source last updated 2024-07-29

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 through up to 2 years or until disease progression

What was measured

TTP is defined as the time from start date of treatment to the date of the first documentation of PD or censoring. TTP is similar to PFS except that death is not treated as an event and is censored. Both new anti-cancer therapy given prior to PD and no PD by the end of follow-up are censoring events

Analysis population: The full analysis set included all enrolled participants.

Groups in this outcome

PF-07209960 1 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.

PF-07209960 3 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.

PF-07209960 10 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.

PF-07209960 15 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.

PF-07209960 20 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.

PF-07209960 30 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
PF-07209960 1 mg SC4
PF-07209960 3 mg SC4
PF-07209960 10 mg SC4
PF-07209960 15 mg SC3
PF-07209960 20 mg SC16
PF-07209960 30 mg SC6

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC3.7Not reported1.4NAUpper limit of 95% CI was not reached due to fewer number of participants with event.
PF-07209960 3 mg SC2.8Not reported2.7NAUpper limit of 95% CI was not reached due to fewer number of participants with event.
PF-07209960 10 mg SC3.8Not reported1.9NAUpper limit of 95% CI was not reached due to fewer number of participants with event.
PF-07209960 15 mg SC1.6Not reported1.5NAUpper limit of 95% CI was not reached due to fewer number of participants with event.
PF-07209960 20 mg SC1.8Not reported1.63.7Not reported
PF-07209960 30 mg SC2.0Not reported0.9NAUpper limit of 95% CI was not reached due to fewer number of participants with event.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of 95% CI was not reached due to fewer number of participants with event.
        group Id
        OG000
        lower Limit
        1.4
        upper Limit
        NA
        value
        3.7
      2. comment
        Upper limit of 95% CI was not reached due to fewer number of participants with event.
        group Id
        OG001
        lower Limit
        2.7
        upper Limit
        NA
        value
        2.8
      3. comment
        Upper limit of 95% CI was not reached due to fewer number of participants with event.
        group Id
        OG002
        lower Limit
        1.9
        upper Limit
        NA
        value
        3.8
      4. comment
        Upper limit of 95% CI was not reached due to fewer number of participants with event.
        group Id
        OG003
        lower Limit
        1.5
        upper Limit
        NA
        value
        1.6
      5. group Id
        OG004
        lower Limit
        1.6
        upper Limit
        3.7
        value
        1.8
      6. comment
        Upper limit of 95% CI was not reached due to fewer number of participants with event.
        group Id
        OG005
        lower Limit
        0.9
        upper Limit
        NA
        value
        2.0
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      16
    6. group Id
      OG005
      value
      6
    units
    Participants
description
TTP is defined as the time from start date of treatment to the date of the first documentation of PD or censoring. TTP is similar to PFS except that death is not treated as an event and is censored. Both new anti-cancer therapy given prior to PD and no PD by the end of follow-up are censoring events
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
    id
    OG000
    title
    PF-07209960 1 mg SC
  2. description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
    id
    OG001
    title
    PF-07209960 3 mg SC
  3. description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
    id
    OG002
    title
    PF-07209960 10 mg SC
  4. description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
    id
    OG003
    title
    PF-07209960 15 mg SC
  5. description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
    id
    OG004
    title
    PF-07209960 20 mg SC
  6. description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
    id
    OG005
    title
    PF-07209960 30 mg SC
param Type
MEDIAN
population Description
The full analysis set included all enrolled participants.
reporting Status
POSTED
time Frame
Baseline through up to 2 years or until disease progression
title
Time to Progression (TTP) in Participants With Progressive Disease Based on Investigator Assessment
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice