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NCT03280264 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2021-05-27

To evaluate the efficacy of KHK7580 orally administered up to 24 weeks for hypercalcemia in patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · 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.

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outcome · 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.

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outcome · POSTED

Serum Corrected Ca Level

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outcome · POSTED

Serum Intact Parathyroid Hormone Level

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outcome · POSTED

Serum Whole Parathyroid Hormone Level

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Personally submitted written voluntary informed consent to participate in the study * Patients with a diagnosis of parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy. * Corrected serum calcium level is \> 11.3 mg/dL at screening. Exclusion Criteria: * Patients receiving cinacalcet hydrochloride within 2 weeks before screening * Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma. * Severe heart disease * Severe hepatic dysfunction * Uncontrolled hypertension and/or diabetes * Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening
healthy Volunteers
false
minimum Age
20 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    oral administration
    intervention Names
    1. Drug: KHK7580
    label
    KHK7580
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. KHK7580
    description
    oral administration
    name
    KHK7580
    other Names
    1. evocalcet
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
18
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    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 Frame
    Up to 24 weeks
secondary Outcomes
  1. measure
    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 Frame
    up to 24 weeks
  2. measure
    Serum Corrected Ca Level
    time Frame
    up to 52 weeks
  3. measure
    Serum Intact Parathyroid Hormone Level
    time Frame
    up to 52 weeks
  4. measure
    Serum Whole Parathyroid Hormone Level
    time Frame
    up to 52 weeks
Full study description
brief Summary
To evaluate the efficacy of KHK7580 orally administered up to 24 weeks for hypercalcemia in patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-bd5f2fd5023d4e527c1a
      requested nct id
      NCT03280264
      primary nct id
      NCT03280264
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2b4988b513f0b70e7c49c0c10cabf5241c1231b8e29e89b78dc9406bd8749c8a
      payload sha256
      96d14f755faed111e24f3f8c7bed068f953b6389cc94d39198a9e433e4bb1b8e
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-bd5f2fd5023d4e527c1a
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT03280264
      occurrences
      1. context exact
        NCT03280264
        end
        11
        exact text
        NCT03280264
        start
        0
      offset unit
      unicode_code_points
      query cond
      Parathyroid Cancer
      query disease state id
      ds-parathyroid-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-parathyroid-cancer-000.json
      source file sha256
      2b4988b513f0b70e7c49c0c10cabf5241c1231b8e29e89b78dc9406bd8749c8a
      source json pointer
      /studies/5/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      966439ea970fbb7912a0f03cc53cd2685fcb90ece119c94d0f5cb77187a22b10

    Preserved source evidence · Not medical advice