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← Soft Tissue Sarcoma

NCT00629343 · STUDY IN CONTEXT

Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. 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

Maximum tolerated dose of temozolomide when used in combination with azacitidine

Source null

→

primary · POSTED

Maximum tolerated dose of azacitidine when used in combination with temozolomide

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-soft-tissue-sarcoma
nct id
NCT00629343
trial label
Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
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
3
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma
    nct id
    NCT00629343
    outcome key
    om-0000
    source section id
    NCT00629343-om-0000
    source outcome index
    0
    endpoint
    Maximum Tolerated Dose of Temozolomide
    endpoint definition
    Maximum tolerated dose of temozolomide when used in combination with azacitidine
    time origin
    Up to 26 weeks for each dosing cohort
    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-soft-tissue-sarcoma
    nct id
    NCT00629343
    outcome key
    om-0001
    source section id
    NCT00629343-om-0001
    source outcome index
    1
    endpoint
    Maximum Tolerated Dose of Azacitidine
    endpoint definition
    Maximum tolerated dose of azacitidine when used in combination with temozolomide
    time origin
    Up to 26 weeks for each dosing cohort
    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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma
    nct id
    NCT00629343
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment
    regimen
    Subjects will receive azacitidine in combination with temozolomide Azacitidine: Azacitidine will be delivered sub-cutaneously for 5 days Temozolomide: Temozolomide will be given starting on day 8 for 5 days at a dose of 200 mg/m2 po qd x 5 days
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00629343-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma
    nct id
    NCT00629343
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment
    regimen
    Subjects will receive azacitidine in combination with temozolomide Azacitidine: Azacitidine will be delivered sub-cutaneously for 5 days Temozolomide: Temozolomide will be given starting on day 8 for 5 days at a dose of 200 mg/m2 po qd x 5 days
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00629343-om-0001#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma
    nct id
    NCT00629343
    harm key
    EG000
    source section id
    NCT00629343-ae
    event group key
    EG000
    event group label
    Azacitidine 25 mg
    serious affected
    0
    serious at risk
    3
    other affected
    0
    other at risk
    3
    frequency threshold
    5
    collection period
    up to 59 months after enrollment
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma
    nct id
    NCT00629343
    harm key
    EG001
    source section id
    NCT00629343-ae
    event group key
    EG001
    event group label
    Azacitidine 50 mg
    serious affected
    0
    serious at risk
    3
    other affected
    0
    other at risk
    3
    frequency threshold
    5
    collection period
    up to 59 months after enrollment
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma
    nct id
    NCT00629343
    harm key
    EG002
    source section id
    NCT00629343-ae
    event group key
    EG002
    event group label
    Azacitidine 75 mg
    serious affected
    15
    serious at risk
    17
    other affected
    0
    other at risk
    17
    frequency threshold
    5
    collection period
    up to 59 months after enrollment
    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