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← recurrent Salivary Gland Cancer

NCT01044433 · STUDY IN CONTEXT

Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

Overall Survival

Source null

→

secondary · POSTED

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Source null

→

secondary · POSTED

Disease Control Rate

Source null

→

secondary · POSTED

Progression-free Survival

Source null

→

secondary · POSTED

ADVERSE EVENTS (AE) AND SERIOUS ADVERSE EVENTS (SAE) Adverse Events (AEs) will use the descriptions and grading scales found in the NCI CTCAE v3.0

Source null

→

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-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01044433
trial label
Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. 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
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
5
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-salivary-gland-cancer-recurrent-79ac7906
    nct id
    NCT01044433
    outcome key
    om-0000
    source section id
    NCT01044433-om-0000
    source outcome index
    0
    endpoint
    Overall Survival
    endpoint definition
    Overall Survival
    time origin
    5 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population 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-salivary-gland-cancer-recurrent-79ac7906
    nct id
    NCT01044433
    outcome key
    om-0001
    source section id
    NCT01044433-om-0001
    source outcome index
    1
    endpoint
    Response Rate
    endpoint definition
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
    time origin
    5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population 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-salivary-gland-cancer-recurrent-79ac7906
    nct id
    NCT01044433
    outcome key
    om-0002
    source section id
    NCT01044433-om-0002
    source outcome index
    2
    endpoint
    Disease Control Rate
    endpoint definition
    Disease Control Rate
    time origin
    5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population 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-salivary-gland-cancer-recurrent-79ac7906
    nct id
    NCT01044433
    outcome key
    om-0003
    source section id
    NCT01044433-om-0003
    source outcome index
    3
    endpoint
    Progression-free Survival
    endpoint definition
    Progression-free Survival
    time origin
    5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population 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-salivary-gland-cancer-recurrent-79ac7906
    nct id
    NCT01044433
    outcome key
    om-0004
    source section id
    NCT01044433-om-0004
    source outcome index
    4
    endpoint
    Number of Participants With Adverse Events and Serious Adverse Events
    endpoint definition
    ADVERSE EVENTS (AE) AND SERIOUS ADVERSE EVENTS (SAE) Adverse Events (AEs) will use the descriptions and grading scales found in the NCI CTCAE v3.0
    time origin
    5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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-salivary-gland-cancer-recurrent-79ac7906
    nct id
    NCT01044433
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Lapatinib Ditosylate and Capecitabine
    regimen
    Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
    analyzed count
    44
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01044433-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-salivary-gland-cancer-recurrent-79ac7906
    nct id
    NCT01044433
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I
    regimen
    Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
    analyzed count
    44
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01044433-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-salivary-gland-cancer-recurrent-79ac7906
    nct id
    NCT01044433
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm I
    regimen
    Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
    analyzed count
    44
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01044433-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-salivary-gland-cancer-recurrent-79ac7906
    nct id
    NCT01044433
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm I
    regimen
    Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
    analyzed count
    44
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01044433-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-salivary-gland-cancer-recurrent-79ac7906
    nct id
    NCT01044433
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Arm I
    regimen
    Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
    analyzed count
    44
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01044433-om-0004#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-salivary-gland-cancer-recurrent-79ac7906
    nct id
    NCT01044433
    harm key
    EG000
    source section id
    NCT01044433-ae
    event group key
    EG000
    event group label
    Lapatinib Ditosylate and Capecitabine
    serious affected
    44
    serious at risk
    44
    other affected
    0
    other at risk
    44
    frequency threshold
    0
    collection period
    Source null
    event definition
    Source null
    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