NCT00896454

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Nov 2009

Geographic Reach
5 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 11, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

November 16, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 1, 2015

Completed
Last Updated

October 17, 2018

Status Verified

September 1, 2018

Enrollment Period

2.8 years

First QC Date

May 7, 2009

Results QC Date

December 19, 2014

Last Update Submit

September 20, 2018

Conditions

Breast CancerHypercalcemia of MalignancyColon CancerEndocrine CancerHead and Neck CancerKidney CancerLung CancerLymphomaMetastatic CancerMultiple MyelomaParathyroid NeoplasmsRenal CancerThyroid CancerHodgkin's LymphomaNon-Hodgkin's LymphomaNon-Small Cell Lung Cancer

Keywords

hypercalcemiacalciumbisphosphonatesdenosumabamgenmalignancy20070315HMConcologyhematology

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With a Response Within 10 Days of First Dose of Denosumab

    Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was \< 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium \[mg/dL\] + (0.8 x (4 - serum albumin \[g/dL\]))

    10 days

Secondary Outcomes (8)

  • Percentage of Participants With a Response by Visit

    Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57

  • Percentage of Participants With a Complete Response by Visit

    Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57

  • Time to Response

    From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.

  • Time to Complete Response

    From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.

  • Duration of Response

    From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.

  • +3 more secondary outcomes

Study Arms (1)

denosumab

EXPERIMENTAL

Eligible subjects will receive denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study days 8 and 15.

Drug: denosumab

Interventions

denosumabDRUG

120 mg subcutaneously (SC) every 4 weeks with a loading dose of 120 mg SC on study days 8 and 15.

denosumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \</= to 30 days before the screening corrected serum calcium
  • Adults (\>/=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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Research Site

Encinitas, California, 92024, United States

Location

Research Site

New Haven, Connecticut, 06520, United States

Location

Research Site

Salisbury, Maryland, 21801, United States

Location

Research Site

Dearborn, Michigan, 48124, United States

Location

Research Site

Detroit, Michigan, 48236, United States

Location

Research Site

Omaha, Nebraska, 68114, United States

Location

Research Site

New York, New York, 10065, United States

Location

Research Site

Syracuse, New York, 13210, United States

Location

Research Site

The Bronx, New York, 10467, United States

Location

Research Site

Durham, North Carolina, 27710, United States

Location

Research Site

Goldsboro, North Carolina, 27534, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Research Site

Québec, Quebec, G1S 4L8, Canada

Location

Research Site

Québec, Quebec, G1S 4L8, Canada

Location

Research Site

Limoges, 87042, France

Location

Research Site

Montpellier, 34298, France

Location

Research Site

Nantes, 44035, France

Location

Research Site

Villejuif, 94805, France

Location

Research Site

Bologna, 40138, Italy

Location

Research Site

Florence, 50139, Italy

Location

Research Site

Milan, 20162, Italy

Location

Research Site

Padua, 35128, Italy

Location

Research Site

Roma, 00128, Italy

Location

Research Site

Warsaw, 01-809, Poland

Location

Related Publications (1)

  • Hu MI, Glezerman I, Leboulleux S, Insogna K, Gucalp R, Misiorowski W, Yu B, Ying W, Jain RK. Denosumab for patients with persistent or relapsed hypercalcemia of malignancy despite recent bisphosphonate treatment. J Natl Cancer Inst. 2013 Sep 18;105(18):1417-20. doi: 10.1093/jnci/djt225. Epub 2013 Aug 29.

    PMID: 23990665DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsHumoral Hypercalcemia Of MalignancyColonic NeoplasmsEndocrine Gland NeoplasmsHead and Neck NeoplasmsKidney NeoplasmsLung NeoplasmsLymphomaNeoplasm MetastasisMultiple MyelomaParathyroid NeoplasmsThyroid NeoplasmsHodgkin DiseaseLymphoma, Non-HodgkinCarcinoma, Non-Small-Cell LungHypercalcemiaNeoplasms

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesEndocrine System DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic DisordersParathyroid DiseasesThyroid DiseasesCarcinoma, BronchogenicBronchial NeoplasmsCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 11, 2009

Study Start

November 16, 2009

Primary Completion

September 13, 2012

Study Completion

August 21, 2013

Last Updated

October 17, 2018

Results First Posted

January 1, 2015

Record last verified: 2018-09

Locations

US(12)CA(2)IT(5)PL(1)FR(4)