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NCT00585195 · OUTCOME

Dose-Escalation Cohort: Number of Participants With Dose-limiting Toxicities (DLT)

A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer · Source last updated 2023-02-08

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
Cycle 1 (28 days)

What was measured

Dose-limiting toxicity (DLT) was defined as any of the following: Hematologic- prolonged grade 4 neutropenia for \>7 days. Febrile neutropenia, defined as grade 4 neutropenia with fever greater than (\>)38.5 degree Celsius, both sustained over a 24 hour period, neutropenic infection: greater than or equal to (\>=)Grade 3 neutropenia with Grade \>=3 infection. Grade \>=3 thrombocytopenia with bleeding or grade 4 lasting \>=7 days Lymphopenia was not considered a DLT unless accompanied by infection. Other non-hematologic toxicity: Grade 3 or 4 toxicities (except for alopecia, Grade 3/4 hypophosphatemia, grade 3 hypertension with controlled blood pressure \[less than (\<) 140/90\], and Grade 3/4 hyperuricemia without signs and symptoms of gout). Nausea, vomiting or diarrhea must persist at grade 3 or 4 despite maximal medical therapy.

Analysis population: SA set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.

Groups in this outcome

Low Dose Escalation Cohort: Crizotinib 50 mg QD

Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).

Low Dose Escalation Cohort: Crizotinib 100 mg QD

Participants received Crizotinib 100 mg capsule or tablet orally QD for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 100 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.

Low Dose Escalation Cohort: Crizotinib 200 mg QD

Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).

Low Dose Escalation Cohort: Crizotinib 200 mg BID

Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).

Low Dose Escalation Cohort: Crizotinib 250 mg BID

Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet BID for up to 34 cycles (each cycle 28 days).

Low Dose Escalation Cohort: Crizotinib 300 mg BID

Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.

High Dose Escalation Cohort: Crizotinib 300 mg QD

Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).

High Dose Escalation Cohort: Crizotinib 400 mg QD

Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).

High Dose Escalation Cohort: Crizotinib 500 mg QD

Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).

High Dose Escalation Cohort: Crizotinib 650 mg QD

Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).

High Dose Escalation Cohort: Crizotinib 800 mg QD

Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 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
Low Dose Escalation Cohort: Crizotinib 50 mg QD3
Low Dose Escalation Cohort: Crizotinib 100 mg QD4
Low Dose Escalation Cohort: Crizotinib 200 mg QD8
Low Dose Escalation Cohort: Crizotinib 200 mg BID7
Low Dose Escalation Cohort: Crizotinib 250 mg BID8
Low Dose Escalation Cohort: Crizotinib 300 mg BID6
High Dose Escalation Cohort: Crizotinib 300 mg QD6
High Dose Escalation Cohort: Crizotinib 400 mg QD5
High Dose Escalation Cohort: Crizotinib 500 mg QD3
High Dose Escalation Cohort: Crizotinib 650 mg QD6
High Dose Escalation Cohort: Crizotinib 800 mg QD9

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Low Dose Escalation Cohort: Crizotinib 50 mg QD0Not reportedNot reportedNot reportedNot reported
Low Dose Escalation Cohort: Crizotinib 100 mg QD0Not reportedNot reportedNot reportedNot reported
Low Dose Escalation Cohort: Crizotinib 200 mg QD1Not reportedNot reportedNot reportedNot reported
Low Dose Escalation Cohort: Crizotinib 200 mg BID0Not reportedNot reportedNot reportedNot reported
Low Dose Escalation Cohort: Crizotinib 250 mg BID0Not reportedNot reportedNot reportedNot reported
Low Dose Escalation Cohort: Crizotinib 300 mg BID2Not reportedNot reportedNot reportedNot reported
High Dose Escalation Cohort: Crizotinib 300 mg QD0Not reportedNot reportedNot reportedNot reported
High Dose Escalation Cohort: Crizotinib 400 mg QD0Not reportedNot reportedNot reportedNot reported
High Dose Escalation Cohort: Crizotinib 500 mg QD0Not reportedNot reportedNot reportedNot reported
High Dose Escalation Cohort: Crizotinib 650 mg QD0Not reportedNot reportedNot reportedNot reported
High Dose Escalation Cohort: Crizotinib 800 mg QD0Not 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
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      7
    5. group Id
      OG004
      value
      8
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      6
    8. group Id
      OG007
      value
      5
    9. group Id
      OG008
      value
      3
    10. group Id
      OG009
      value
      6
    11. group Id
      OG010
      value
      9
    units
    Participants
description
Dose-limiting toxicity (DLT) was defined as any of the following: Hematologic- prolonged grade 4 neutropenia for \>7 days. Febrile neutropenia, defined as grade 4 neutropenia with fever greater than (\>)38.5 degree Celsius, both sustained over a 24 hour period, neutropenic infection: greater than or equal to (\>=)Grade 3 neutropenia with Grade \>=3 infection. Grade \>=3 thrombocytopenia with bleeding or grade 4 lasting \>=7 days Lymphopenia was not considered a DLT unless accompanied by infection. Other non-hematologic toxicity: Grade 3 or 4 toxicities (except for alopecia, Grade 3/4 hypophosphatemia, grade 3 hypertension with controlled blood pressure \[less than (\<) 140/90\], and Grade 3/4 hyperuricemia without signs and symptoms of gout). Nausea, vomiting or diarrhea must persist at grade 3 or 4 despite maximal medical therapy.
groups
  1. description
    Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).
    id
    OG000
    title
    Low Dose Escalation Cohort: Crizotinib 50 mg QD
  2. description
    Participants received Crizotinib 100 mg capsule or tablet orally QD for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 100 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
    id
    OG001
    title
    Low Dose Escalation Cohort: Crizotinib 100 mg QD
  3. description
    Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).
    id
    OG002
    title
    Low Dose Escalation Cohort: Crizotinib 200 mg QD
  4. description
    Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).
    id
    OG003
    title
    Low Dose Escalation Cohort: Crizotinib 200 mg BID
  5. description
    Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet BID for up to 34 cycles (each cycle 28 days).
    id
    OG004
    title
    Low Dose Escalation Cohort: Crizotinib 250 mg BID
  6. description
    Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
    id
    OG005
    title
    Low Dose Escalation Cohort: Crizotinib 300 mg BID
  7. description
    Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    id
    OG006
    title
    High Dose Escalation Cohort: Crizotinib 300 mg QD
  8. description
    Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    id
    OG007
    title
    High Dose Escalation Cohort: Crizotinib 400 mg QD
  9. description
    Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    id
    OG008
    title
    High Dose Escalation Cohort: Crizotinib 500 mg QD
  10. description
    Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).
    id
    OG009
    title
    High Dose Escalation Cohort: Crizotinib 650 mg QD
  11. description
    Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    id
    OG010
    title
    High Dose Escalation Cohort: Crizotinib 800 mg QD
param Type
COUNT_OF_PARTICIPANTS
population Description
SA set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.
reporting Status
POSTED
time Frame
Cycle 1 (28 days)
title
Dose-Escalation Cohort: Number of Participants With Dose-limiting Toxicities (DLT)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice