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← OPDIVO: unresectable metastatic Squamous Cell Carcinoma after prior therapy

NCT00513435 · STUDY IN CONTEXT

Saracatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic 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

Response was determined as inicated in the protocol.

Source null

→

secondary · POSTED

The Kaplan-Meier method will be used to estimate overall survival.

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-squamous-cell-carcinoma-opdivo-8e2ac10c
nct id
NCT00513435
trial label
Saracatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
applicability
unclear
applicability note
Attached because the study's own record describes metastatic 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
2
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT00513435
    outcome key
    om-0000
    source section id
    NCT00513435-om-0000
    source outcome index
    0
    endpoint
    Overall Response Rate
    endpoint definition
    Response was determined as inicated in the protocol.
    time origin
    From the start of treatment for up to 12 weeks
    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-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT00513435
    outcome key
    om-0001
    source section id
    NCT00513435-om-0001
    source outcome index
    1
    endpoint
    Overall Survival
    endpoint definition
    The Kaplan-Meier method will be used to estimate overall survival.
    time origin
    Up to 12 weeks
    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-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT00513435
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00513435-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT00513435
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00513435-om-0001#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT00513435
    harm key
    EG000
    source section id
    NCT00513435-ae
    event group key
    EG000
    event group label
    Treatment (Enzyme Inhibitor Therapy)
    serious affected
    5
    serious at risk
    9
    other affected
    9
    other at risk
    9
    frequency threshold
    5
    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