Phase 3
Completed N=18
Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism
Thyroid Cancer · Primary Hyperparathyroidism
Source: ClinicalTrials.gov NCT03280264 ↗
Enrolled (actual)
18
Serious AEs
16.7%
Results posted
May 2021
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 | — |
| SECONDARY 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 | — |
| SECONDARY Serum Corrected Ca Level |
9.89 | — |
| SECONDARY Serum Intact Parathyroid Hormone Level |
152.6 | — |
| SECONDARY Serum Whole Parathyroid Hormone Level |
108.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT03280264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.