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← Ovarian Neoplasm

NCT00551070 · STUDY IN CONTEXT

Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer

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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Complete and Partial Tumor Response by (Response Evaluation Criteria in Solid Tumors) RECIST 1.0

Eligible and treated patients

→

primary · POSTED

Adverse Events (Grade 3 or Higher) During First Cycle of Treatment

Eligible and treated patients.

→

primary · POSTED

Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily.

Eligible and Treated Patients with all pharmacokinetic time points available

→

primary · POSTED

Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily.

Eligible and Treated Patients with at least one post-dose pharmacokinetic time point available

→

secondary · POSTED

Progression-free Survival

Eligible and Treated Patients

→

secondary · POSTED

Number of Courses Received

Eligible and Treated Patients. Two patients still on study and have received 68 and 79 cycles of treatment.

→

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-ovarian-neoplasm
nct id
NCT00551070
trial label
Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer
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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00551070
    outcome key
    om-0000
    source section id
    NCT00551070-om-0000
    source outcome index
    0
    endpoint
    Tumor Response
    endpoint definition
    Complete and Partial Tumor Response by (Response Evaluation Criteria in Solid Tumors) RECIST 1.0
    time origin
    Every other cycle
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and treated patients
    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-ovarian-neoplasm
    nct id
    NCT00551070
    outcome key
    om-0003
    source section id
    NCT00551070-om-0003
    source outcome index
    3
    endpoint
    Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
    endpoint definition
    Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
    time origin
    Cycle 1
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and treated patients.
    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-ovarian-neoplasm
    nct id
    NCT00551070
    outcome key
    om-0004
    source section id
    NCT00551070-om-0004
    source outcome index
    4
    endpoint
    Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily.
    endpoint definition
    Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily.
    time origin
    Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and Treated Patients with all pharmacokinetic time points available
    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-ovarian-neoplasm
    nct id
    NCT00551070
    outcome key
    om-0005
    source section id
    NCT00551070-om-0005
    source outcome index
    5
    endpoint
    Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily.
    endpoint definition
    Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily.
    time origin
    Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and Treated Patients with at least one post-dose pharmacokinetic time point available
    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-ovarian-neoplasm
    nct id
    NCT00551070
    outcome key
    om-0001
    source section id
    NCT00551070-om-0001
    source outcome index
    1
    endpoint
    Progression-free Survival
    endpoint definition
    Progression-free Survival
    time origin
    Every other cycle
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and Treated Patients
    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-ovarian-neoplasm
    nct id
    NCT00551070
    outcome key
    om-0002
    source section id
    NCT00551070-om-0002
    source outcome index
    2
    endpoint
    Number of Courses Received
    endpoint definition
    Number of Courses Received
    time origin
    Every cycle
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and Treated Patients. Two patients still on study and have received 68 and 79 cycles of treatment.
    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-ovarian-neoplasm
    nct id
    NCT00551070
    outcome key
    om-0000
    arm key
    OG000
    arm label
    AZD6244
    regimen
    AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
    analyzed count
    52
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00551070-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00551070
    outcome key
    om-0001
    arm key
    OG000
    arm label
    AZD6244
    regimen
    AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
    analyzed count
    52
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00551070-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00551070
    outcome key
    om-0002
    arm key
    OG000
    arm label
    AZD6244
    regimen
    AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
    analyzed count
    52
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00551070-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00551070
    outcome key
    om-0003
    arm key
    OG000
    arm label
    AZD6244
    regimen
    AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
    analyzed count
    52
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00551070-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00551070
    outcome key
    om-0004
    arm key
    OG000
    arm label
    AZD6244
    regimen
    AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
    analyzed count
    41
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00551070-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00551070
    outcome key
    om-0005
    arm key
    OG000
    arm label
    AZD6244
    regimen
    AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
    analyzed count
    42
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00551070-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00551070
    harm key
    EG000
    source section id
    NCT00551070-ae
    event group key
    EG000
    event group label
    AZD6244
    serious affected
    33
    serious at risk
    52
    other affected
    52
    other at risk
    52
    frequency threshold
    0
    collection period
    Study Treatment
    event definition
    Includes all adverse events reported (grade 1-5) regardless of attribution.
    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