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← recurrent Salivary Gland Cancer

NCT01604772 · STUDY IN CONTEXT

Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst Carcinoma

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

Confirmed response rate will be reported as the number of participants achieving either a complete response or partial response (using RECIST v1.1) divided by the number of evaluable participants. In order for a participant to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart. Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

Two patients were deemed ineligible for this endpoint due to eligibility criteria not being met. Therefore, this endpoint is reported using 14 eligible patients.

→

secondary · POSTED

Progression Free Survival is defined as the time from registration to the earliest date of documentation of disease progression or death. The distribution of time to progression will be estimated using the method of Kaplan-Meier.

Two patients were deemed ineligible and were not included in this endpoint.

→

secondary · POSTED

Overall Survival is defined as the time from registration to death. The distribution of survival will be estimated using the method of Kaplan-MeierEstimated using Kaplan-Meier methodology.

Two patients were not eligible for this endpoint.

→

secondary · POSTED

Safety will be assessed in terms of the number of participants reporting grade 3 or higher adverse events as evaluated by Common Terminology Criteria for Adverse Events v4.0 (CTCAE).

All patients that started protocol treatment were included in this analysis.

→

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
NCT01604772
trial label
Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst Carcinoma
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
4
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
    NCT01604772
    outcome key
    om-0000
    source section id
    NCT01604772-om-0000
    source outcome index
    0
    endpoint
    Confirmed Response Rate (Complete Response + Partial Response) According to RECIST Version 1.1
    endpoint definition
    Confirmed response rate will be reported as the number of participants achieving either a complete response or partial response (using RECIST v1.1) divided by the number of evaluable participants. In order for a participant to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart. Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
    time origin
    Up to 32 weeks
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Two patients were deemed ineligible for this endpoint due to eligibility criteria not being met. Therefore, this endpoint is reported using 14 eligible 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-salivary-gland-cancer-recurrent-79ac7906
    nct id
    NCT01604772
    outcome key
    om-0001
    source section id
    NCT01604772-om-0001
    source outcome index
    1
    endpoint
    Median Progression Free Survival
    endpoint definition
    Progression Free Survival is defined as the time from registration to the earliest date of documentation of disease progression or death. The distribution of time to progression will be estimated using the method of Kaplan-Meier.
    time origin
    Time of study entry to progression or death, up to 3 years after registration
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Two patients were deemed ineligible and were not included in this endpoint.
    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
    NCT01604772
    outcome key
    om-0002
    source section id
    NCT01604772-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    Overall Survival is defined as the time from registration to death. The distribution of survival will be estimated using the method of Kaplan-MeierEstimated using Kaplan-Meier methodology.
    time origin
    Time of study entry to death due to any cause, assessed up to 3 years from registration
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Two patients were not eligible for this endpoint.
    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
    NCT01604772
    outcome key
    om-0003
    source section id
    NCT01604772-om-0003
    source outcome index
    3
    endpoint
    Incidence of Toxicities of Akt Inhibitor MK-2206
    endpoint definition
    Safety will be assessed in terms of the number of participants reporting grade 3 or higher adverse events as evaluated by Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
    time origin
    Time to first treatment to up to 30 days after completion of treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All patients that started protocol treatment were included in this analysis.
    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
    NCT01604772
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Akt Inhibitor MK2206)
    regimen
    Treatment (Akt Inhibitor MK2206)
    analyzed count
    14
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01604772-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-salivary-gland-cancer-recurrent-79ac7906
    nct id
    NCT01604772
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Akt Inhibitor MK2206)
    regimen
    Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: 150 mg given PO
    analyzed count
    14
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01604772-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-salivary-gland-cancer-recurrent-79ac7906
    nct id
    NCT01604772
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Akt Inhibitor MK2206)
    regimen
    Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: 150 mg given PO
    analyzed count
    14
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01604772-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-salivary-gland-cancer-recurrent-79ac7906
    nct id
    NCT01604772
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Akt Inhibitor MK2206)
    regimen
    Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: 150 mg given PO
    analyzed count
    16
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01604772-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-salivary-gland-cancer-recurrent-79ac7906
    nct id
    NCT01604772
    harm key
    EG000
    source section id
    NCT01604772-ae
    event group key
    EG000
    event group label
    Treatment (Akt Inhibitor MK2206)
    serious affected
    2
    serious at risk
    16
    other affected
    16
    other at risk
    16
    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