Phase 2
Completed N=33
Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium
Breast Cancer · Hypercalcemia of Malignancy · Colorectal Cancer · Endocrine Cancer
Source: ClinicalTrials.gov NCT00896454 ↗
Enrolled (actual)
33
Serious AEs
87.9%
Results posted
Jan 2015
Primary outcomePrimary: Percentage of Participants With a Response Within 10 Days of First Dose of Denosumab — 63.6 percentage of participants
Summary
The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering corrected serum calcium </= 11.5 mg/dL (2.9 millimoles /L) by day 10.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Response Within 10 Days of First Dose of Denosumab |
63.6 | — |
| SECONDARY Percentage of Participants With a Response by Visit |
9.1; 24.2; 48.5; 63.6; 63.6; 69.7 | — |
| SECONDARY Percentage of Participants With a Complete Response by Visit |
3.0; 15.2; 27.3; 36.4; 45.5; 45.5 | — |
| SECONDARY Time to Response |
9.0 | — |
| SECONDARY Time to Complete Response |
23.0 | — |
| SECONDARY Duration of Response |
104.0 | — |
| SECONDARY Duration of Complete Response |
34.0 | — |
| SECONDARY Time to Relapse/Nonresponse of Hypercalcemia of Malignancy |
19.0 | — |
| SECONDARY Change From Baseline in Corrected Serum Calcium |
-0.13; -0.25; -0.43; -0.54; -0.51; -0.64 | — |
Eligibility Criteria
Inclusion Criteria
- Hypercalcemia of Malignancy (HCM) as defined as documented histologically or cytologically confirmed cancer and a corrected serum calcium (CSC) > 12.5 mg/dL (3.1 millimoles /L) at screening by local laboratory
- Last IV bisphosphonate treatment must be >/= to 7 days and /=18 years)
- Adequate organ function as defined by the following criteria:
- serum aspartate aminotransferase (AST) </= 5 x upper limit of normal (ULN)
- serum alanine aminotransferase (ALT) </= 5 x upper limit of normal
- serum total bilirubin </= 2 x upper limit of normal
Exclusion Criteria
- Evidence of benign hyperparathyroidism, hyperthyroidism, adrenal insufficiency, vitamin D intoxication, milk alkali syndrome, sarcoidosis, or other granulomatous disease
- Receiving dialysis for renal failure
- Treatment with thiazides, calcitonin, mithramycin, or gallium nitrate within their window of expected therapeutic effect (as determined by the physician) prior to the date of the screening CSC
- Treatment with cinacalcet within 4 weeks prior to the date of the screening CSC
- Thirty days or less since receiving an investigational product (other than denosumab) or device (ie, does not have marketing authorization; thalidomide use is allowed) in another clinical study
- Known sensitivity to any of the products to be administered during the study (eg, mammalian derived products)
- Female subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment
- Female subject of childbearing potential is not willing to use 2 highly effective methods of contraception during treatment and for 7 months after the end of treatment
- Subject will not be available for follow-up assessment.
- Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
Data sourced from ClinicalTrials.gov (NCT00896454). 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.