A Study of an Investigational Medication for Severe Primary Hyperparathyroidism or Parathyroid Cancer

May 6, 2013 updated by: Amgen

An Assessment of the Calcimimetic Agent AMG 073 for the Treatment of Subjects With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism.

This study will assess an investigational medication for patients with severe primary hyperparathyroidism or parathyroid cancer.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment

46

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Patients must have parathyroid carcinoma or severe primary hyperparathyroidism; * Abnormally elevated calcium levels above 12.5 mg/dL; * Not be pregnant or nursing; * Not have had any type of cancer other than parathyroid carcinoma within the last 5 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Changes in serum calcium and PTH

Secondary Outcome Measures

Outcome Measure
Safety and tolerability of cinacalcet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Registration Dates

First Submitted

May 17, 2002

First Submitted That Met QC Criteria

May 17, 2002

First Posted (Estimate)

May 20, 2002

Study Record Updates

Last Update Posted (Estimate)

May 8, 2013

Last Update Submitted That Met QC Criteria

May 6, 2013

Last Verified

May 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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