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NCT01970865 · OUTCOME

Number of Participants With Absolute Values and Change From Baseline in PR Interval Meeting Pre-defined Criteria (Phase 2 and DDI Substudy)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose of study treatment to end of treatment maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)

What was measured

PR Interval was determined by ECG measurement. PR interval had following categories: change from baseline\>=25 percent, 40 to \<60 milliseconds (msec), 60 to \<80 msec and \>=80 msec. Baseline was defined as the average of the triplicate measurements prior to the first dose of study drug.

Analysis population: Safety analysis set: all enrolled participants who received at least 1 dose of PF-06463922. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.

Groups in this outcome

EXP-1 (Phase 2)

Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) 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.

EXP-2 (Phase 2)

Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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.

EXP-3 (Phase 2)

Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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.

EXP-4 (Phase 2)

Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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.

EXP-5 (Phase 2)

Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) 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.

EXP-6 (Phase 2)

Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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.

DDI Substudy

Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.

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

Analysis denominator · Participants

GroupSource count
EXP-1 (Phase 2)29
EXP-2 (Phase 2)27
EXP-3 (Phase 2)59
EXP-4 (Phase 2)64
EXP-5 (Phase 2)46
EXP-6 (Phase 2)47
DDI Substudy32

Reported measurements

Change from baseline: >25%
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EXP-1 (Phase 2)4Not reportedNot reportedNot reportedNot reported
EXP-2 (Phase 2)3Not reportedNot reportedNot reportedNot reported
EXP-3 (Phase 2)8Not reportedNot reportedNot reportedNot reported
EXP-4 (Phase 2)9Not reportedNot reportedNot reportedNot reported
EXP-5 (Phase 2)6Not reportedNot reportedNot reportedNot reported
EXP-6 (Phase 2)10Not reportedNot reportedNot reportedNot reported
DDI Substudy2Not reportedNot reportedNot reportedNot reported
Absolute value: 40-<60 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EXP-1 (Phase 2)3Not reportedNot reportedNot reportedNot reported
EXP-2 (Phase 2)2Not reportedNot reportedNot reportedNot reported
EXP-3 (Phase 2)2Not reportedNot reportedNot reportedNot reported
EXP-4 (Phase 2)2Not reportedNot reportedNot reportedNot reported
EXP-5 (Phase 2)3Not reportedNot reportedNot reportedNot reported
EXP-6 (Phase 2)7Not reportedNot reportedNot reportedNot reported
DDI Substudy2Not reportedNot reportedNot reportedNot reported
Absolute value: 60-<80 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EXP-1 (Phase 2)0Not reportedNot reportedNot reportedNot reported
EXP-2 (Phase 2)1Not reportedNot reportedNot reportedNot reported
EXP-3 (Phase 2)2Not reportedNot reportedNot reportedNot reported
EXP-4 (Phase 2)4Not reportedNot reportedNot reportedNot reported
EXP-5 (Phase 2)1Not reportedNot reportedNot reportedNot reported
EXP-6 (Phase 2)1Not reportedNot reportedNot reportedNot reported
DDI Substudy0Not reportedNot reportedNot reportedNot reported
Absolute value: >=80 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EXP-1 (Phase 2)1Not reportedNot reportedNot reportedNot reported
EXP-2 (Phase 2)0Not reportedNot reportedNot reportedNot reported
EXP-3 (Phase 2)0Not reportedNot reportedNot reportedNot reported
EXP-4 (Phase 2)1Not reportedNot reportedNot reportedNot reported
EXP-5 (Phase 2)1Not reportedNot reportedNot reportedNot reported
EXP-6 (Phase 2)2Not reportedNot reportedNot reportedNot reported
DDI Substudy0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        10
      7. group Id
        OG006
        value
        2
    title
    Change from baseline: >25%
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        7
      7. group Id
        OG006
        value
        2
    title
    Absolute value: 40-<60 msec
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
    title
    Absolute value: 60-<80 msec
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        0
    title
    Absolute value: >=80 msec
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    2. group Id
      OG001
      value
      27
    3. group Id
      OG002
      value
      59
    4. group Id
      OG003
      value
      64
    5. group Id
      OG004
      value
      46
    6. group Id
      OG005
      value
      47
    7. group Id
      OG006
      value
      32
    units
    Participants
description
PR Interval was determined by ECG measurement. PR interval had following categories: change from baseline\>=25 percent, 40 to \<60 milliseconds (msec), 60 to \<80 msec and \>=80 msec. Baseline was defined as the average of the triplicate measurements prior to the first dose of study drug.
groups
  1. description
    Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) 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
    EXP-1 (Phase 2)
  2. description
    Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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
    OG001
    title
    EXP-2 (Phase 2)
  3. description
    Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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
    EXP-3 (Phase 2)
  4. description
    Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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
    EXP-4 (Phase 2)
  5. description
    Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) 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
    EXP-5 (Phase 2)
  6. description
    Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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
    OG005
    title
    EXP-6 (Phase 2)
  7. description
    Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
    id
    OG006
    title
    DDI Substudy
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set: all enrolled participants who received at least 1 dose of PF-06463922. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
From first dose of study treatment to end of treatment maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)
title
Number of Participants With Absolute Values and Change From Baseline in PR Interval Meeting Pre-defined Criteria (Phase 2 and DDI Substudy)
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice