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CompletedNCT03280264Updated May 27, 2021Results posted

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

A Phase 3 interventional study of KHK7580 in Parathyroid Carcinoma and Primary Hyperparathyroidism, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-05-27.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Parathyroid Carcinoma
  • Primary Hyperparathyroidism
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    KHK7580

    oral administration

    Drug: KHK7580

Interventions

  • DrugKHK7580

    oral administration

    Also known as: evocalcet

05

What researchers measure

Primary outcomes

  1. 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. 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. Serum Corrected Ca Level

    Time frame: up to 52 weeks

  3. Serum Intact Parathyroid Hormone Level

    Time frame: up to 52 weeks

  4. Serum Whole Parathyroid Hormone Level

    Time frame: up to 52 weeks

06

Results

Posted May 27, 2021

Participant flow

Participant flow — Overall Study
MilestoneKHK7580 (2-24 mg)
Started18
Completed15
Not completed3
Withdrew: Adverse event1
Withdrew: Physician decision1
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryThe 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
Reported as:
Count of participants · Participants
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.
ParticipantsKHK7580 (2-24 mg)
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.14
SecondaryThe 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
Reported as:
Count of participants · Participants
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.
ParticipantsKHK7580 (2-24 mg)
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.12
SecondarySerum Corrected Ca Level
Time frame:
up to 52 weeks
Reported as:
Mean · mg/dL
Serum Corrected Ca Level
mg/dLKHK7580 (2-24 mg)
Serum Corrected Ca Level9.89 ± 0.60
SecondarySerum Intact Parathyroid Hormone Level
Time frame:
up to 52 weeks
Reported as:
Mean · pg/dL
Serum Intact Parathyroid Hormone Level
pg/dLKHK7580 (2-24 mg)
Serum Intact Parathyroid Hormone Level152.6 ± 97.3
SecondarySerum Whole Parathyroid Hormone Level
Time frame:
up to 52 weeks
Reported as:
Mean · pg/dL
Serum Whole Parathyroid Hormone Level
pg/dLKHK7580 (2-24 mg)
Serum Whole Parathyroid Hormone Level108.9 ± 73.0

Adverse events

Collected over up to 52week. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
KHK7580 (2-24 mg)0/18 (0%)3/18 (16.7%)18/18 (100%)
Most frequent serious events
Most frequent serious events
EventKHK7580 (2-24 mg)
enterocolitisGastrointestinal disorders1/18
urinary tract infectionRenal and urinary disorders1/18
uterine cancerReproductive system and breast disorders1/18
Most frequent other events
Showing 10 of 50
Most frequent other events
EventKHK7580 (2-24 mg)
NasopharyngitisInfections and infestations7/18
NauseaGastrointestinal disorders3/18
Chest painGeneral disorders2/18
CystitisInfections and infestations2/18
InfluenzaInfections and infestations2/18
ArthralgiaMusculoskeletal and connective tissue disorders2/18
Back painMusculoskeletal and connective tissue disorders2/18
MyalgiaMusculoskeletal and connective tissue disorders2/18
HeadacheNervous system disorders2/18
Iron deficiency anaemiaBlood and lymphatic system disorders1/18

Baseline characteristics

Age, Continuous
Age, Continuous(years)KHK7580 (2-24 mg)
Mean62.2 ± 11.9
Sex: Female, Male
Sex: Female, Male(Participants)KHK7580 (2-24 mg)
Female13
Male5
Race (NIH/OMB)
Race (NIH/OMB)(Participants)KHK7580 (2-24 mg)
American Indian or Alaska Native0
Asian18
Native Hawaiian or Other Pacific Islander0
Black or African American0
White0
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)KHK7580 (2-24 mg)
Japan18
serum corrected Ca conc.
serum corrected Ca conc.(mg/dL)KHK7580 (2-24 mg)
Mean11.73 ± 0.84
serum intact Parathyroid Hormone conc.
serum intact Parathyroid Hormone conc.(pg/mL)KHK7580 (2-24 mg)
Mean507.7 ± 1409.8
parathyroid carcinoma
parathyroid carcinoma(Participants)KHK7580 (2-24 mg)
Count of participants3
Unable to undergo parathyroidectomy
Unable to undergo parathyroidectomy(participants)KHK7580 (2-24 mg)
Number13

5 further baseline measures are reported on the registry.

07

Study locations

1 site
  • Osaka City University Hospital
    Ōsaka, Japan
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 30, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03280264
Lead sponsor
Kyowa Kirin Co., Ltd.
Responsible party
Sponsor
First posted
Sep 12, 2017
Start date
Aug 30, 2017
Primary completion
Apr 9, 2019
Completion
Apr 9, 2019
Results posted
May 27, 2021
Last update
May 27, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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