Trial Outcomes & Findings for Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism (NCT NCT03280264)
NCT ID: NCT03280264
Last Updated: 2021-05-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
18 participants
Primary outcome timeframe
Up to 24 weeks
Results posted on
2021-05-27
Participant Flow
Participant milestones
| Measure |
KHK7580 (2-24 mg)
KHK7580 was orally administered daily for up to week 52.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
KHK7580 (2-24 mg)
KHK7580 was orally administered daily for up to week 52.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism
Baseline characteristics by cohort
| Measure |
KHK7580 (2-24 mg)
n=18 Participants
KHK7580 was orally administered daily for up to week 52.
|
|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
18 Participants
n=5 Participants
|
|
serum corrected Ca conc.
|
11.73 mg/dL
STANDARD_DEVIATION 0.84 • n=5 Participants
|
|
serum intact Parathyroid Hormone conc.
|
507.7 pg/mL
STANDARD_DEVIATION 1409.8 • n=5 Participants
|
|
parathyroid carcinoma
|
3 Participants
n=5 Participants
|
|
Unable to undergo parathyroidectomy
|
13 participants
n=5 Participants
|
|
Relapse after parathyroidectomy
|
2 participants
n=5 Participants
|
|
previous cinacalcet use
|
13 participants
n=5 Participants
|
|
Pharmacotherapy for primary diseases
|
3 participants
n=5 Participants
|
|
parathyroidectomy
|
6 participants
n=5 Participants
|
|
Parathyroid intervention therapy
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksOutcome measures
| Measure |
KHK7580 (2-24 mg)
n=18 Participants
KHK7580 was orally administered daily for up to week 52.
|
|---|---|
|
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.
|
14 Participants
|
SECONDARY outcome
Timeframe: up to 24 weeksOutcome measures
| Measure |
KHK7580 (2-24 mg)
n=18 Participants
KHK7580 was orally administered daily for up to week 52.
|
|---|---|
|
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.
|
12 Participants
|
SECONDARY outcome
Timeframe: up to 52 weeksOutcome measures
| Measure |
KHK7580 (2-24 mg)
n=18 Participants
KHK7580 was orally administered daily for up to week 52.
|
|---|---|
|
Serum Corrected Ca Level
|
9.89 mg/dL
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: up to 52 weeksOutcome measures
| Measure |
KHK7580 (2-24 mg)
n=18 Participants
KHK7580 was orally administered daily for up to week 52.
|
|---|---|
|
Serum Intact Parathyroid Hormone Level
|
152.6 pg/dL
Standard Deviation 97.3
|
SECONDARY outcome
Timeframe: up to 52 weeksOutcome measures
| Measure |
KHK7580 (2-24 mg)
n=18 Participants
KHK7580 was orally administered daily for up to week 52.
|
|---|---|
|
Serum Whole Parathyroid Hormone Level
|
108.9 pg/dL
Standard Deviation 73.0
|
Adverse Events
KHK7580 (2-24 mg)
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KHK7580 (2-24 mg)
n=18 participants at risk
KHK7580 was orally administered daily for up to week 52.
|
|---|---|
|
Gastrointestinal disorders
enterocolitis
|
5.6%
1/18 • up to 52week
|
|
Renal and urinary disorders
urinary tract infection
|
5.6%
1/18 • up to 52week
|
|
Reproductive system and breast disorders
uterine cancer
|
5.6%
1/18 • up to 52week
|
Other adverse events
| Measure |
KHK7580 (2-24 mg)
n=18 participants at risk
KHK7580 was orally administered daily for up to week 52.
|
|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
5.6%
1/18 • up to 52week
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
5.6%
1/18 • up to 52week
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • up to 52week
|
|
Eye disorders
Cataract
|
5.6%
1/18 • up to 52week
|
|
Eye disorders
Cataract cortical
|
5.6%
1/18 • up to 52week
|
|
Eye disorders
Ocular hyperaemia
|
5.6%
1/18 • up to 52week
|
|
Gastrointestinal disorders
Nausea
|
16.7%
3/18 • up to 52week
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.6%
1/18 • up to 52week
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.6%
1/18 • up to 52week
|
|
Gastrointestinal disorders
Dental caries
|
5.6%
1/18 • up to 52week
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • up to 52week
|
|
Gastrointestinal disorders
Enterocolitis
|
5.6%
1/18 • up to 52week
|
|
Gastrointestinal disorders
Stomatitis
|
5.6%
1/18 • up to 52week
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • up to 52week
|
|
Gastrointestinal disorders
Faeces soft
|
5.6%
1/18 • up to 52week
|
|
General disorders
Chest pain
|
11.1%
2/18 • up to 52week
|
|
General disorders
Hangover
|
5.6%
1/18 • up to 52week
|
|
Infections and infestations
Nasopharyngitis
|
38.9%
7/18 • up to 52week
|
|
Infections and infestations
Cystitis
|
11.1%
2/18 • up to 52week
|
|
Infections and infestations
Influenza
|
11.1%
2/18 • up to 52week
|
|
Infections and infestations
Bronchitis
|
5.6%
1/18 • up to 52week
|
|
Infections and infestations
Conjunctivitis
|
5.6%
1/18 • up to 52week
|
|
Infections and infestations
Gastroenteritis
|
5.6%
1/18 • up to 52week
|
|
Infections and infestations
Hordeolum
|
5.6%
1/18 • up to 52week
|
|
Infections and infestations
Otitis externa
|
5.6%
1/18 • up to 52week
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18 • up to 52week
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • up to 52week
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • up to 52week
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • up to 52week
|
|
Infections and infestations
Viral infection
|
5.6%
1/18 • up to 52week
|
|
Injury, poisoning and procedural complications
Head injury
|
5.6%
1/18 • up to 52week
|
|
Injury, poisoning and procedural complications
Heat stroke
|
5.6%
1/18 • up to 52week
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
5.6%
1/18 • up to 52week
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
5.6%
1/18 • up to 52week
|
|
Injury, poisoning and procedural complications
Radiation sickness syndrome
|
5.6%
1/18 • up to 52week
|
|
Investigations
Blood creatinine increased
|
5.6%
1/18 • up to 52week
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
2/18 • up to 52week
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
2/18 • up to 52week
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
2/18 • up to 52week
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • up to 52week
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
5.6%
1/18 • up to 52week
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • up to 52week
|
|
Nervous system disorders
Dysgeusia
|
5.6%
1/18 • up to 52week
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • up to 52week
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
5.6%
1/18 • up to 52week
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
5.6%
1/18 • up to 52week
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.6%
1/18 • up to 52week
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • up to 52week
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.6%
1/18 • up to 52week
|
|
Vascular disorders
Hypertension
|
5.6%
1/18 • up to 52week
|
Additional Information
Research & Development Planning Department, Research & Development Division
Kyowa Kirin Co., Ltd.
Phone: +81-3-5205-7200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place