Parathyroid Carcinoma, Primary Hyperparathyroidism
Conditions
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.
Interventions
DRUGKHK7580
oral administration
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Up to 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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. | up to 24 weeks |
| Serum Corrected Ca Level | up to 52 weeks |
| Serum Intact Parathyroid Hormone Level | up to 52 weeks |
| Serum Whole Parathyroid Hormone Level | up to 52 weeks |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| KHK7580 (2-24 mg) KHK7580 was orally administered daily for up to week 52. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | KHK7580 (2-24 mg) |
|---|---|
| Age, Continuous | 62.2 years STANDARD_DEVIATION 11.9 |
| parathyroid carcinoma | 3 Participants |
| parathyroidectomy | 6 participants |
| Parathyroid intervention therapy | 0 participants |
| Pharmacotherapy for primary diseases | 3 participants |
| previous cinacalcet use | 13 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 18 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Japan | 18 Participants |
| Relapse after parathyroidectomy | 2 participants |
| serum corrected Ca conc. | 11.73 mg/dL STANDARD_DEVIATION 0.84 |
| serum intact Parathyroid Hormone conc. | 507.7 pg/mL STANDARD_DEVIATION 1409.8 |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 5 Participants |
| Unable to undergo parathyroidectomy | 13 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 18 / 18 |
| serious Total, serious adverse events | 3 / 18 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| KHK7580 (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 Participants |
Secondary
Serum Corrected Ca Level
Time frame: up to 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KHK7580 (2-24 mg) | Serum Corrected Ca Level | 9.89 mg/dL | Standard Deviation 0.6 |
Secondary
Serum Intact Parathyroid Hormone Level
Time frame: up to 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KHK7580 (2-24 mg) | Serum Intact Parathyroid Hormone Level | 152.6 pg/dL | Standard Deviation 97.3 |
Secondary
Serum Whole Parathyroid Hormone Level
Time frame: up to 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KHK7580 (2-24 mg) | Serum Whole Parathyroid Hormone Level | 108.9 pg/dL | Standard Deviation 73 |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| KHK7580 (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 Participants |