Hypercalcemia in patients with parathyroid carcinoma or intractable PHPT.
Conditions
Interventions
investigational material(s)
Generic name etc : KRN1493
INN of investigational material : cinacalcet
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for In
Sponsors
Kyowa Hakko Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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 follow: 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
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 | — |
Outcome results
None listed