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

NCT01460030 | Completed Phase 3

• 1 other identifier: KRN1493-101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Parathyroid Carcinoma; Hypercalcemia; Primary Hyperparathyroidism

Keywords

Hypercalcemia in patients with parathyroid carcinoma or intractable PHPT

Outcome Measures

Primary Outcomes (1)

• Corrected serum calcium

Secondary Outcomes (1)

• Serum intact parathyroid hormone

Study Arms (1)

KRN1493

EXPERIMENTAL

Drug: Cinacalcet HCl

Interventions

Cinacalcet HCl DRUG

Oral administration

KRN1493

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Sendai, Japan

Location

MeSH Terms

Conditions

Parathyroid Neoplasms; Hypercalcemia; Hyperparathyroidism, Primary

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Parathyroid Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Hyperparathyroidism

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 26, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 3, 2017

Record last verified: 2017-02

Locations

JP (1)