Back to resultsPhase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism
Primary Purpose
Parathyroid Carcinoma, Primary Hyperparathyroidism
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KHK7580
Sponsored by
About this trial
This is an interventional treatment trial for Parathyroid Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Personally submitted written voluntary informed consent to participate in the study
- Patients with a diagnosis of parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.
- Corrected serum calcium level is > 11.3 mg/dL at screening.
Exclusion Criteria:
- Patients receiving cinacalcet hydrochloride within 2 weeks before screening
- Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma.
- Severe heart disease
- Severe hepatic dysfunction
- Uncontrolled hypertension and/or diabetes
- Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening
Sites / Locations
- Osaka City University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KHK7580
Arm Description
oral administration
Outcomes
Primary Outcome Measures
The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase.
Secondary Outcome Measures
The Number and Percentage of Patients in Whom the Decrease in Serum Corrected Ca Concentration From the Baseline Was ≥ 1.0 mg/dL for ≥ 2 Weeks During the Titration Phase.
Serum Corrected Ca Level
Serum Intact Parathyroid Hormone Level
Serum Whole Parathyroid Hormone Level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03280264
Brief Title
Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism
Official Title
An Intra-Subject Dose-Adjustment Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism Who Are Unable to Undergo Parathyroidectomy or Relapse After Parathyroidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
April 9, 2019 (Actual)
Study Completion Date
April 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy of KHK7580 orally administered up to 24 weeks for hypercalcemia in patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parathyroid Carcinoma, Primary Hyperparathyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KHK7580
Arm Type
Experimental
Arm Description
oral administration
Intervention Type
Drug
Intervention Name(s)
KHK7580
Other Intervention Name(s)
evocalcet
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
The Number and Percentage of Patients in Whom the Decrease in Serum Corrected Ca Concentration From the Baseline Was ≥ 1.0 mg/dL for ≥ 2 Weeks During the Titration Phase.
Time Frame
up to 24 weeks
Title
Serum Corrected Ca Level
Time Frame
up to 52 weeks
Title
Serum Intact Parathyroid Hormone Level
Time Frame
up to 52 weeks
Title
Serum Whole Parathyroid Hormone Level
Time Frame
up to 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Personally submitted written voluntary informed consent to participate in the study
Patients with a diagnosis of parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.
Corrected serum calcium level is > 11.3 mg/dL at screening.
Exclusion Criteria:
Patients receiving cinacalcet hydrochloride within 2 weeks before screening
Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma.
Severe heart disease
Severe hepatic dysfunction
Uncontrolled hypertension and/or diabetes
Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening
Facility Information:
Facility Name
Osaka City University Hospital
City
Ōsaka
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism
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