Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02659631 · OUTCOME

Number of Participants With OR - Part 1

PF-06671008 Dose Escalation Study in Advanced Solid Tumors · Source last updated 2020-05-06

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline and every 6 weeks for the first 6 months, then every 12 weeks until disease progression, unacceptable toxicity, or up to 24 months

What was measured

Number of participants with OR based on assessment of CR or PR according to RECIST v1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

Analysis population: All randomized participants who received at least 1 dose of study intervention, had measurable disease baseline assessment and at least 1 post baseline assessment or disease progression or death before the first tumor assessment. No participants met the criteria of OR.

Groups in this outcome

PF-06671008 1.5 ng/kg IV

PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.

PF-06671008 7.5 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.

PF-06671008 20 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.

PF-06671008 50 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.

PF-06671008 100 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.

PF-06671008 200 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.

PF-06671008 300 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.

PF-06671008 400 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.

PF-06671008 200 ng/kg SC

PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.

PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.

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-06671008 1.5 ng/kg IV1
PF-06671008 7.5 ng/kg IV2
PF-06671008 20 ng/kg IV3
PF-06671008 50 ng/kg IV2
PF-06671008 100 ng/kg IV4
PF-06671008 200 ng/kg IV5
PF-06671008 300 ng/kg IV4
PF-06671008 400 ng/kg IV3
PF-06671008 200 ng/kg SC2
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV1

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06671008 1.5 ng/kg IV0Not reportedNot reportedNot reportedNot reported
PF-06671008 7.5 ng/kg IV0Not reportedNot reportedNot reportedNot reported
PF-06671008 20 ng/kg IV0Not reportedNot reportedNot reportedNot reported
PF-06671008 50 ng/kg IV0Not reportedNot reportedNot reportedNot reported
PF-06671008 100 ng/kg IV0Not reportedNot reportedNot reportedNot reported
PF-06671008 200 ng/kg IV0Not reportedNot reportedNot reportedNot reported
PF-06671008 300 ng/kg IV0Not reportedNot reportedNot reportedNot reported
PF-06671008 400 ng/kg IV0Not reportedNot reportedNot reportedNot reported
PF-06671008 200 ng/kg SC0Not reportedNot reportedNot reportedNot reported
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      4
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      2
    10. group Id
      OG009
      value
      1
    units
    Participants
description
Number of participants with OR based on assessment of CR or PR according to RECIST v1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
groups
  1. description
    PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    OG000
    title
    PF-06671008 1.5 ng/kg IV
  2. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
    id
    OG001
    title
    PF-06671008 7.5 ng/kg IV
  3. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    OG002
    title
    PF-06671008 20 ng/kg IV
  4. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
    id
    OG003
    title
    PF-06671008 50 ng/kg IV
  5. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    OG004
    title
    PF-06671008 100 ng/kg IV
  6. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
    id
    OG005
    title
    PF-06671008 200 ng/kg IV
  7. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    OG006
    title
    PF-06671008 300 ng/kg IV
  8. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
    id
    OG007
    title
    PF-06671008 400 ng/kg IV
  9. description
    PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
    id
    OG008
    title
    PF-06671008 200 ng/kg SC
  10. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    OG009
    title
    PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
param Type
COUNT_OF_PARTICIPANTS
population Description
All randomized participants who received at least 1 dose of study intervention, had measurable disease baseline assessment and at least 1 post baseline assessment or disease progression or death before the first tumor assessment. No participants met the criteria of OR.
reporting Status
POSTED
time Frame
Baseline and every 6 weeks for the first 6 months, then every 12 weeks until disease progression, unacceptable toxicity, or up to 24 months
title
Number of Participants With OR - Part 1
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice