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NCT00585195 · STUDY IN CONTEXT

A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

Draft scope assessment: unclear. Attached because the study's own record names ALK. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

MTD: Dose level at which at most 1 of 6 participants experienced DLT within and including 28 days of treatment (during Cycle 1 \[1 cycle=28 days\]) with next higher dose having at least 2/3 or 2/6 participants experiencing a DLT. DLT was defined as any of following: Hematologic toxicities- 1) prolonged grade 4 neutropenia for \>7 days. 2) Febrile neutropenia: grade 4 neutropenia with fever greater than (\>) 38.5 degree Celsius, both sustained over a 24 hour period (3) neutropenic infection: greater than or equal to (\>=) Grade 3 neutropenia with Grade \>=3 infection. (4) Grade \>=3 thrombocytopenia with bleeding/grade 4 lasting \>=7 days. Other non-hematologic toxicity included: Grade 3/4 toxicities (except for alopecia, Grade 3/4 hypophosphatemia, grade 3 hypertension with controlled blood pressure \[less than (\<) 140/90 millimeter of mercury, and Grade 3/4 hyperuricemia without signs and symptoms of gout). Nausea, vomiting/diarrhea must persist at grade 3/4 despite maximal medical therapy.

Safety analysis (SA) set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.

→

primary · POSTED

RP2D was defined as a dose below or equal to MTD, at which crizotinib was unlikely to cause a significant inhibition of CYP3A4 activity.

Safety analysis (SA) set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.

→

primary · POSTED

AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (0-inf).

Pharmacokinetic (PK) parameter analysis population included all participants treated (including Day -7 dose) who had at least 1 of the PK parameters of interest for Crizotinib. "Overall number of participants analyzed (N)" signifies participants evaluable for this outcome measure (OM). Data for this OM was planned to be collected for individual arms of low and high dose escalation and combined RP2D Cohort excluding "Low Dose Escalation Cohort: Crizotinib 100 mg QD" arm.

→

primary · POSTED

Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose.

PK parameter analysis population included all participants treated (including Day -7 dose) who had at least 1 of the PK parameters of interest for Crizotinib. Here, "N" signifies participants evaluable for this OM. Data for this OM was planned to be reported for individual arms of low and high dose escalation and combined RP2D Cohort excluding "Low Dose Escalation Cohort: Crizotinib 100 mg QD" arm.

→

primary · POSTED

Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose.

PK parameter analysis population included all participants treated (including Day -7 dose) who had at least 1 of the PK parameters of interest for Crizotinib. Here, "N" signifies participants evaluable for this OM. Data for this OM was planned to be collected for low dose escalation cohort (excluding Crizotinib 50 mg QD, Crizotinib 200 mg QD and Crizotinib 250 mg BID arms) and combined RP2D cohort and was not planned to be collected for high dose escalation cohort.

→

primary · POSTED

Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose.

The PK parameter analysis population included all participants treated (including Day -7 dose) who have at least 1 of the PK parameters of interest for Crizotinib. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measures was planned to be collected for individual arms of dose escalation cohorts and combined RP2D Cohort.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-axtle-caa7b626
nct id
NCT00585195
trial label
A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer
applicability
unclear
applicability note
Attached because the study's own record names ALK. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
21
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0000
    source section id
    NCT00585195-om-0000
    source outcome index
    0
    endpoint
    Dose-Escalation Cohort: Maximum Tolerated Dose (MTD) of Crizotinib
    endpoint definition
    MTD: Dose level at which at most 1 of 6 participants experienced DLT within and including 28 days of treatment (during Cycle 1 \[1 cycle=28 days\]) with next higher dose having at least 2/3 or 2/6 participants experiencing a DLT. DLT was defined as any of following: Hematologic toxicities- 1) prolonged grade 4 neutropenia for \>7 days. 2) Febrile neutropenia: grade 4 neutropenia with fever greater than (\>) 38.5 degree Celsius, both sustained over a 24 hour period (3) neutropenic infection: greater than or equal to (\>=) Grade 3 neutropenia with Grade \>=3 infection. (4) Grade \>=3 thrombocytopenia with bleeding/grade 4 lasting \>=7 days. Other non-hematologic toxicity included: Grade 3/4 toxicities (except for alopecia, Grade 3/4 hypophosphatemia, grade 3 hypertension with controlled blood pressure \[less than (\<) 140/90 millimeter of mercury, and Grade 3/4 hyperuricemia without signs and symptoms of gout). Nausea, vomiting/diarrhea must persist at grade 3/4 despite maximal medical therapy.
    time origin
    Cycle 1 (28 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety analysis (SA) set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0001
    source section id
    NCT00585195-om-0001
    source outcome index
    1
    endpoint
    Dose-Escalation Cohort: Recommended Phase 2 Dose (RP2D) of Crizotinib
    endpoint definition
    RP2D was defined as a dose below or equal to MTD, at which crizotinib was unlikely to cause a significant inhibition of CYP3A4 activity.
    time origin
    Cycle 1 (28 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety analysis (SA) set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0002
    source section id
    NCT00585195-om-0002
    source outcome index
    2
    endpoint
    Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Crizotinib on Day -7
    endpoint definition
    AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (0-inf).
    time origin
    Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Pharmacokinetic (PK) parameter analysis population included all participants treated (including Day -7 dose) who had at least 1 of the PK parameters of interest for Crizotinib. "Overall number of participants analyzed (N)" signifies participants evaluable for this outcome measure (OM). Data for this OM was planned to be collected for individual arms of low and high dose escalation and combined RP2D Cohort excluding "Low Dose Escalation Cohort: Crizotinib 100 mg QD" arm.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0003
    source section id
    NCT00585195-om-0003
    source outcome index
    3
    endpoint
    Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Day -7
    endpoint definition
    Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose.
    time origin
    Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    PK parameter analysis population included all participants treated (including Day -7 dose) who had at least 1 of the PK parameters of interest for Crizotinib. Here, "N" signifies participants evaluable for this OM. Data for this OM was planned to be reported for individual arms of low and high dose escalation and combined RP2D Cohort excluding "Low Dose Escalation Cohort: Crizotinib 100 mg QD" arm.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0004
    source section id
    NCT00585195-om-0004
    source outcome index
    4
    endpoint
    Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Cycle 1 Day 1
    endpoint definition
    Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose.
    time origin
    Pre-dose, 2, 4 and 6 hours post dose on Cycle 1 Day 1
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    PK parameter analysis population included all participants treated (including Day -7 dose) who had at least 1 of the PK parameters of interest for Crizotinib. Here, "N" signifies participants evaluable for this OM. Data for this OM was planned to be collected for low dose escalation cohort (excluding Crizotinib 50 mg QD, Crizotinib 200 mg QD and Crizotinib 250 mg BID arms) and combined RP2D cohort and was not planned to be collected for high dose escalation cohort.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0005
    source section id
    NCT00585195-om-0005
    source outcome index
    5
    endpoint
    Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Cycle 1 Day 15
    endpoint definition
    Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose.
    time origin
    Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The PK parameter analysis population included all participants treated (including Day -7 dose) who have at least 1 of the PK parameters of interest for Crizotinib. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measures was planned to be collected for individual arms of dose escalation cohorts and combined RP2D Cohort.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Low Dose Escalation Cohort: Crizotinib 50 mg QD
    regimen
    Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00585195-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Low Dose Escalation Cohort: Crizotinib 100 mg QD
    regimen
    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.
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00585195-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Low Dose Escalation Cohort: Crizotinib 200 mg QD
    regimen
    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).
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00585195-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Low Dose Escalation Cohort: Crizotinib 200 mg BID
    regimen
    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).
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00585195-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0000
    arm key
    OG004
    arm label
    Low Dose Escalation Cohort: Crizotinib 250 mg BID
    regimen
    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).
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00585195-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0000
    arm key
    OG005
    arm label
    Low Dose Escalation Cohort: Crizotinib 300 mg BID
    regimen
    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.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00585195-om-0000#groups/OG005
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0000
    arm key
    OG006
    arm label
    High Dose Escalation Cohort: Crizotinib 300 mg QD
    regimen
    Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00585195-om-0000#groups/OG006
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0000
    arm key
    OG007
    arm label
    High Dose Escalation Cohort: Crizotinib 400 mg QD
    regimen
    Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00585195-om-0000#groups/OG007
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0000
    arm key
    OG008
    arm label
    High Dose Escalation Cohort: Crizotinib 500 mg QD
    regimen
    Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00585195-om-0000#groups/OG008
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0000
    arm key
    OG009
    arm label
    High Dose Escalation Cohort: Crizotinib 650 mg QD
    regimen
    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).
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00585195-om-0000#groups/OG009
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0000
    arm key
    OG010
    arm label
    High Dose Escalation Cohort: Crizotinib 800 mg QD
    regimen
    Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00585195-om-0000#groups/OG010
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Low Dose Escalation Cohort: Crizotinib 50 mg QD
    regimen
    Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00585195-om-0001#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    harm key
    EG000
    source section id
    NCT00585195-ae
    event group key
    EG000
    event group label
    Low Dose Escalation Cohort: Crizotinib 50 mg QD
    serious affected
    0
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    Up to maximum of 189 months
    event definition
    Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    harm key
    EG001
    source section id
    NCT00585195-ae
    event group key
    EG001
    event group label
    Low Dose Escalation Cohort: Crizotinib 100 mg QD
    serious affected
    0
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    5
    collection period
    Up to maximum of 189 months
    event definition
    Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    harm key
    EG002
    source section id
    NCT00585195-ae
    event group key
    EG002
    event group label
    Low Dose Escalation Cohort: Crizotinib 200 mg QD
    serious affected
    1
    serious at risk
    8
    other affected
    8
    other at risk
    8
    frequency threshold
    5
    collection period
    Up to maximum of 189 months
    event definition
    Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    harm key
    EG003
    source section id
    NCT00585195-ae
    event group key
    EG003
    event group label
    Low Dose Escalation Cohort: Crizotinib 200 mg BID
    serious affected
    2
    serious at risk
    7
    other affected
    7
    other at risk
    7
    frequency threshold
    5
    collection period
    Up to maximum of 189 months
    event definition
    Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    harm key
    EG004
    source section id
    NCT00585195-ae
    event group key
    EG004
    event group label
    Low Dose Escalation Cohort: Crizotinib 250 mg BID
    serious affected
    4
    serious at risk
    8
    other affected
    8
    other at risk
    8
    frequency threshold
    5
    collection period
    Up to maximum of 189 months
    event definition
    Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    harm key
    EG005
    source section id
    NCT00585195-ae
    event group key
    EG005
    event group label
    Low Dose Escalation Cohort: Crizotinib 300 mg BID
    serious affected
    2
    serious at risk
    6
    other affected
    6
    other at risk
    6
    frequency threshold
    5
    collection period
    Up to maximum of 189 months
    event definition
    Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    harm key
    EG006
    source section id
    NCT00585195-ae
    event group key
    EG006
    event group label
    High Dose Escalation Cohort: Crizotinib 300 mg QD
    serious affected
    2
    serious at risk
    6
    other affected
    6
    other at risk
    6
    frequency threshold
    5
    collection period
    Up to maximum of 189 months
    event definition
    Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    harm key
    EG007
    source section id
    NCT00585195-ae
    event group key
    EG007
    event group label
    High Dose Escalation Cohort: Crizotinib 400 mg QD
    serious affected
    2
    serious at risk
    5
    other affected
    4
    other at risk
    5
    frequency threshold
    5
    collection period
    Up to maximum of 189 months
    event definition
    Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    harm key
    EG008
    source section id
    NCT00585195-ae
    event group key
    EG008
    event group label
    High Dose Escalation Cohort: Crizotinib 500 mg QD
    serious affected
    1
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    Up to maximum of 189 months
    event definition
    Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    harm key
    EG009
    source section id
    NCT00585195-ae
    event group key
    EG009
    event group label
    High Dose Escalation Cohort: Crizotinib 650 mg QD
    serious affected
    2
    serious at risk
    6
    other affected
    6
    other at risk
    6
    frequency threshold
    5
    collection period
    Up to maximum of 189 months
    event definition
    Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    harm key
    EG010
    source section id
    NCT00585195-ae
    event group key
    EG010
    event group label
    High Dose Escalation Cohort: Crizotinib 800 mg QD
    serious affected
    4
    serious at risk
    9
    other affected
    9
    other at risk
    9
    frequency threshold
    5
    collection period
    Up to maximum of 189 months
    event definition
    Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-axtle-caa7b626
    nct id
    NCT00585195
    harm key
    EG011
    source section id
    NCT00585195-ae
    event group key
    EG011
    event group label
    RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg
    serious affected
    24
    serious at risk
    53
    other affected
    53
    other at risk
    53
    frequency threshold
    5
    collection period
    Up to maximum of 189 months
    event definition
    Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice