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NCT02573259 · OUTCOME

Time to Progression (TTP) Based on RECIST Version 1.1 and irRECIST - Part 2

A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors · Source last updated 2021-12-13

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 up to end of treatment in Part 2 (maximum of 851 days)

What was measured

TTP was the time to objective progression. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. TTP was analyzed by the Kaplan-Meier approach for each tumor type.

Analysis population: Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.

Groups in this outcome

Part 2: PF-06801591 300 mg (SC) for NSCLC

Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)

Part 2: PF-06801591 300 mg (SC) for UC

Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)

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 2: PF-06801591 300 mg (SC) for NSCLC67
Part 2: PF-06801591 300 mg (SC) for UC38

Reported measurements

RECIST v1.1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC3.7Not reported1.95.7Not reported
Part 2: PF-06801591 300 mg (SC) for UC3.7Not reported1.98.5Not reported
irRECIST
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC6.5Not reported3.710.3Not reported
Part 2: PF-06801591 300 mg (SC) for UC8.5Not reported2.519.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        upper Limit
        5.7
        value
        3.7
      2. group Id
        OG001
        lower Limit
        1.9
        upper Limit
        8.5
        value
        3.7
    title
    RECIST v1.1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.7
        upper Limit
        10.3
        value
        6.5
      2. group Id
        OG001
        lower Limit
        2.5
        upper Limit
        19.4
        value
        8.5
    title
    irRECIST
denoms
  1. counts
    1. group Id
      OG000
      value
      67
    2. group Id
      OG001
      value
      38
    units
    Participants
description
TTP was the time to objective progression. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. TTP was analyzed by the Kaplan-Meier approach for each tumor type.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
    id
    OG000
    title
    Part 2: PF-06801591 300 mg (SC) for NSCLC
  2. description
    Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
    id
    OG001
    title
    Part 2: PF-06801591 300 mg (SC) for UC
param Type
MEDIAN
population Description
Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.
reporting Status
POSTED
time Frame
Baseline up to end of treatment in Part 2 (maximum of 851 days)
title
Time to Progression (TTP) Based on RECIST Version 1.1 and irRECIST - Part 2
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice