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A Single-arm, Multicenter, Proof-of-concept Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium Despite Recent Treatment With IV Bisphosphonates


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Hypercalcemia of Malignancy, Colon Cancer, Endocrine Cancer, Head and Neck Cancer, Kidney Cancer, Lung Cancer, Lymphoma, Metastatic Cancer, Multiple Myeloma, Parathyroid Neoplasms, Renal Cancer, Thyroid Cancer, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Non-Small Cell Lung Cancer

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Trial Information

A Single-arm, Multicenter, Proof-of-concept Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium Despite Recent Treatment With IV Bisphosphonates


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 screening corrected serum calcium

- Adults (>/=18 years)

- Adequate organ function as defined by the following criteria:

- serum aspartate aminotransferase (AST)
- serum alanine aminotransferase (ALT)
- serum total bilirubin
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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of subjects with a response, defined as corrected serum calcium

Outcome Time Frame:

10 days

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20070315

NCT ID:

NCT00896454

Start Date:

November 2009

Completion Date:

November 2013

Related Keywords:

  • Breast Cancer
  • Hypercalcemia of Malignancy
  • Colon Cancer
  • Endocrine Cancer
  • Head and Neck Cancer
  • Kidney Cancer
  • Lung Cancer
  • Lymphoma
  • Metastatic Cancer
  • Multiple Myeloma
  • Parathyroid Neoplasms
  • Renal Cancer
  • Thyroid Cancer
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Non-Small Cell Lung Cancer
  • hypercalcemia
  • calcium
  • bisphosphonates
  • denosumab
  • amgen
  • malignancy
  • 20070315
  • HMC
  • oncology
  • hematology
  • Breast Neoplasms
  • Neoplasms
  • Colonic Neoplasms
  • Thyroid Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Head and Neck Neoplasms
  • Hodgkin Disease
  • Hypercalcemia
  • Lung Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Parathyroid Neoplasms
  • Endocrine Gland Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteDanbury, Connecticut  
Research SiteBaltimore, Maryland  
Research SiteBattle Kreek, Michigan  
Research SiteGrand Island, Nebraska  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAbilene, Texas