An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism
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.