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← Parathyroid Cancer

NCT03280264 · STUDY IN CONTEXT

Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism

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

The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase.

Source null

→

secondary · POSTED

The Number and Percentage of Patients in Whom the Decrease in Serum Corrected Ca Concentration From the Baseline Was ≥ 1.0 mg/dL for ≥ 2 Weeks During the Titration Phase.

Source null

→

secondary · POSTED

Serum Corrected Ca Level

Source null

→

secondary · POSTED

Serum Intact Parathyroid Hormone Level

Source null

→

secondary · POSTED

Serum Whole Parathyroid Hormone Level

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-parathyroid-cancer
nct id
NCT03280264
trial label
Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism
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
5
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-parathyroid-cancer
    nct id
    NCT03280264
    outcome key
    om-0000
    source section id
    NCT03280264-om-0000
    source outcome index
    0
    endpoint
    The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase.
    endpoint definition
    The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase.
    time origin
    Up to 24 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-parathyroid-cancer
    nct id
    NCT03280264
    outcome key
    om-0001
    source section id
    NCT03280264-om-0001
    source outcome index
    1
    endpoint
    The Number and Percentage of Patients in Whom the Decrease in Serum Corrected Ca Concentration From the Baseline Was ≥ 1.0 mg/dL for ≥ 2 Weeks During the Titration Phase.
    endpoint definition
    The Number and Percentage of Patients in Whom the Decrease in Serum Corrected Ca Concentration From the Baseline Was ≥ 1.0 mg/dL for ≥ 2 Weeks During the Titration Phase.
    time origin
    up to 24 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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-parathyroid-cancer
    nct id
    NCT03280264
    outcome key
    om-0002
    source section id
    NCT03280264-om-0002
    source outcome index
    2
    endpoint
    Serum Corrected Ca Level
    endpoint definition
    Serum Corrected Ca Level
    time origin
    up to 52 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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-parathyroid-cancer
    nct id
    NCT03280264
    outcome key
    om-0003
    source section id
    NCT03280264-om-0003
    source outcome index
    3
    endpoint
    Serum Intact Parathyroid Hormone Level
    endpoint definition
    Serum Intact Parathyroid Hormone Level
    time origin
    up to 52 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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-parathyroid-cancer
    nct id
    NCT03280264
    outcome key
    om-0004
    source section id
    NCT03280264-om-0004
    source outcome index
    4
    endpoint
    Serum Whole Parathyroid Hormone Level
    endpoint definition
    Serum Whole Parathyroid Hormone Level
    time origin
    up to 52 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-parathyroid-cancer
    nct id
    NCT03280264
    outcome key
    om-0000
    arm key
    OG000
    arm label
    KHK7580 (2-24 mg)
    regimen
    KHK7580 was orally administered daily for up to week 52.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03280264-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-parathyroid-cancer
    nct id
    NCT03280264
    outcome key
    om-0001
    arm key
    OG000
    arm label
    KHK7580 (2-24 mg)
    regimen
    KHK7580 was orally administered daily.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03280264-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-parathyroid-cancer
    nct id
    NCT03280264
    outcome key
    om-0002
    arm key
    OG000
    arm label
    KHK7580 (2-24 mg)
    regimen
    KHK7580 was orally administered daily.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03280264-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-parathyroid-cancer
    nct id
    NCT03280264
    outcome key
    om-0003
    arm key
    OG000
    arm label
    KHK7580 (2-24 mg)
    regimen
    KHK7580 was orally administered daily.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03280264-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-parathyroid-cancer
    nct id
    NCT03280264
    outcome key
    om-0004
    arm key
    OG000
    arm label
    KHK7580 (2-24 mg)
    regimen
    KHK7580 was orally administered daily.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03280264-om-0004#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-parathyroid-cancer
    nct id
    NCT03280264
    harm key
    EG000
    source section id
    NCT03280264-ae
    event group key
    EG000
    event group label
    KHK7580 (2-24 mg)
    serious affected
    3
    serious at risk
    18
    other affected
    18
    other at risk
    18
    frequency threshold
    0
    collection period
    up to 52week
    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