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NCT01970865 · OUTCOME

Time for Cmax (Tmax) of PF-06463922 Following Single Oral Doses (Phase 1)

A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations · Source last updated 2024-08-12

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

Measure
MEDIAN
Unit
Hours
Interval / dispersion
Full Range
Time frame
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.

What was measured

Tmax of PF-06463922 was observed directly from data as time of first occurrence.

Analysis population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.

Groups in this outcome

10 mg QD (Phase 1)

PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

25 mg QD (Phase 1)

PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.

50 mg QD (Phase 1)

PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

75 mg QD (Phase 1)

PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

100 mg QD (Phase 1)

PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

150 mg QD (Phase 1)

PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.

200 mg QD (Phase 1)

PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

35 mg BID (Phase 1)

PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

75 mg BID (Phase 1)

PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

100 mg BID (Phase 1)

PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

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

Analysis denominator · Participants

GroupSource count
10 mg QD (Phase 1)3
25 mg QD (Phase 1)3
50 mg QD (Phase 1)2
75 mg QD (Phase 1)12
100 mg QD (Phase 1)16
150 mg QD (Phase 1)3
200 mg QD (Phase 1)3
35 mg BID (Phase 1)3
75 mg BID (Phase 1)3
100 mg BID (Phase 1)4

Reported measurements

Source class 1
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
10 mg QD (Phase 1)1.98Not reported1.002.97Not reported
25 mg QD (Phase 1)2.00Not reported0.502.05Not reported
50 mg QD (Phase 1)1.25Not reported0.502.00Not reported
75 mg QD (Phase 1)1.09Not reported0.504.03Not reported
100 mg QD (Phase 1)1.96Not reported0.5174.33Not reported
150 mg QD (Phase 1)1.05Not reported1.003.00Not reported
200 mg QD (Phase 1)2.00Not reported1.183.00Not reported
35 mg BID (Phase 1)1.20Not reported0.501.97Not reported
75 mg BID (Phase 1)1.23Not reported1.002.00Not reported
100 mg BID (Phase 1)2.00Not reported1.103.07Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        2.97
        value
        1.98
      2. group Id
        OG001
        lower Limit
        0.50
        upper Limit
        2.05
        value
        2.00
      3. group Id
        OG002
        lower Limit
        0.50
        upper Limit
        2.00
        value
        1.25
      4. group Id
        OG003
        lower Limit
        0.50
        upper Limit
        4.03
        value
        1.09
      5. group Id
        OG004
        lower Limit
        0.517
        upper Limit
        4.33
        value
        1.96
      6. group Id
        OG005
        lower Limit
        1.00
        upper Limit
        3.00
        value
        1.05
      7. group Id
        OG006
        lower Limit
        1.18
        upper Limit
        3.00
        value
        2.00
      8. group Id
        OG007
        lower Limit
        0.50
        upper Limit
        1.97
        value
        1.20
      9. group Id
        OG008
        lower Limit
        1.00
        upper Limit
        2.00
        value
        1.23
      10. group Id
        OG009
        lower Limit
        1.10
        upper Limit
        3.07
        value
        2.00
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      12
    5. group Id
      OG004
      value
      16
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      3
    10. group Id
      OG009
      value
      4
    units
    Participants
description
Tmax of PF-06463922 was observed directly from data as time of first occurrence.
dispersion Type
Full Range
groups
  1. description
    PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
    id
    OG000
    title
    10 mg QD (Phase 1)
  2. description
    PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
    id
    OG001
    title
    25 mg QD (Phase 1)
  3. description
    PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
    id
    OG002
    title
    50 mg QD (Phase 1)
  4. description
    PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
    id
    OG003
    title
    75 mg QD (Phase 1)
  5. description
    PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
    id
    OG004
    title
    100 mg QD (Phase 1)
  6. description
    PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
    id
    OG005
    title
    150 mg QD (Phase 1)
  7. description
    PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
    id
    OG006
    title
    200 mg QD (Phase 1)
  8. description
    PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
    id
    OG007
    title
    35 mg BID (Phase 1)
  9. description
    PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
    id
    OG008
    title
    75 mg BID (Phase 1)
  10. description
    PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
    id
    OG009
    title
    100 mg BID (Phase 1)
param Type
MEDIAN
population Description
PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.
reporting Status
POSTED
time Frame
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.
title
Time for Cmax (Tmax) of PF-06463922 Following Single Oral Doses (Phase 1)
type
SECONDARY
unit Of Measure
Hours

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice