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

Sponsor

Kyowa Kirin Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01460030

Collaborator

(none)

Location

Arm

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Parathyroid Carcinoma Hypercalcemia Primary Hyperparathyroidism	Drug: Cinacalcet HCl	Phase 3

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KRN1493	Drug: Cinacalcet HCl Oral administration

Arm

Intervention/Treatment

Experimental: KRN1493

Drug: Cinacalcet HCl

Oral administration

Outcome Measures

Primary Outcome Measures

Corrected serum calcium []

Secondary Outcome Measures

Serum intact parathyroid hormone []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.