Hypercalcemia, Parathyroid Carcinoma, Primary Hyperparathyroidism
Conditions
Keywords
Hypercalcemia in patients with parathyroid carcinoma or intractable PHPT
Brief summary
This is an intra-individual titration study of KRN1493 to evaluate the safety and efficacy of KRN1493 for the treatment of hypercalcemia in patients with parathyroid carcinoma or intractable primary hyperparathyroidism (PHPT).
Interventions
DRUGCinacalcet HCl
Oral administration
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who meet any one of the following. Patients with a diagnosis of parathyroid carcinoma and corrected serum calcium \> 11.3 mg/dL at the latest screening test. Patients with intractable PHPT (defined as follows: impossible to localize parathyroid tumor before initial surgery or in relapse after surgery, or impossible to perform parathyroidectomy (PTx) for complications, and corrected serum calcium is \> 12.5 mg/dL at the screening test). * Patients who provided their voluntary written informed consent to participate in the study.
Exclusion criteria
* Patients diagnosed with malignant tumor except for parathyroid carcinoma, nonmelanoma skin cancer, and carcinoma in situ of the cervix within 5 years before enrollment. * Patients receiving anticancer chemotherapy except for the treatment of parathyroid carcinoma. * Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma. * Patients who had hypersensitivities to cinacalcet HCl preparations or vehicles.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corrected serum calcium | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum intact parathyroid hormone | — |
Countries
Japan
Outcome results
None listed