Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00104650
First received: March 3, 2005
Last updated: January 20, 2011
Last verified: January 2011
Results First Received: December 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Bone Metastases in Men With Hormone-Refractory Prostate Cancer
Bone Metastases in Subjects With Advanced Breast Cancer
Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
Interventions: Genetic: AMG 162 180 mg (SC) q 12 weeks
Drug: IV Bisphosphonate q 4 weeks
Genetic: AMG 162- 180 mg q 4 weeks

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 2 December 2004 through 30 March 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bisphosphonate IV Q4W Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
Denosumab 180 mg Q12W Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
Denosumab 180 mg Q4W Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)

Participant Flow for 2 periods

Period 1:   Treatment Period (25 Weeks)
    Bisphosphonate IV Q4W     Denosumab 180 mg Q12W     Denosumab 180 mg Q4W  
STARTED     37     36     38  
Received Investigational Product     35     35     38  
COMPLETED     25     25     28  
NOT COMPLETED     12     11     10  
Physician Decision                 0                 0                 1  
Withdrawal by Subject                 2                 1                 1  
Death                 7                 5                 6  
Disease progression                 2                 3                 2  
Ineligibility determined                 0                 1                 0  
Other                 1                 0                 0  
Protocol deviation                 0                 1                 0  

Period 2:   Follow-up Period
    Bisphosphonate IV Q4W     Denosumab 180 mg Q12W     Denosumab 180 mg Q4W  
STARTED     25     25     28  
COMPLETED     14     12     18  
NOT COMPLETED     11     13     10  
Physician Decision                 1                 1                 0  
Adverse Event                 1                 0                 1  
Withdrawal by Subject                 0                 3                 3  
Death                 6                 6                 4  
Disease progression                 3                 1                 0  
Lost to Follow-up                 0                 1                 2  
Other                 0                 1                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Denosumab 180 mg Q4W Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
Bisphosphonate IV Q4W Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
Denosumab 180 mg Q12W Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
Total Total of all reporting groups

Baseline Measures
    Denosumab 180 mg Q4W     Bisphosphonate IV Q4W     Denosumab 180 mg Q12W     Total  
Number of Participants  
[units: participants]
  38     37     36     111  
Age  
[units: Years]
Mean ± Standard Deviation
  60.6  ± 10.7     61.6  ± 11.7     65.3  ± 12.7     62.5  ± 11.8  
Gender  
[units: Participants]
       
Female     19     18     19     56  
Male     19     19     17     55  
Race/Ethnicity, Customized  
[units: Participants]
       
White or Caucasian     22     22     19     63  
Black or African American     0     0     1     1  
Hispanic or Latino     16     13     15     44  
Asian     0     1     0     1  
Native Hawaiian or Other Pacific Islander     0     1     0     1  
Other     0     0     1     1  
Cancer Type Stratification Factor  
[units: Participants]
       
Breast cancer     16     16     14     46  
Prostate cancer     17     17     16     50  
Mutiple myeloma     2     3     4     9  
Other solid tumor     3     1     2     6  
Urinary N-telopeptide (uNTx) Level [1]
[units: nmol/mmol]
Mean ± Standard Deviation
  149.94  ± 147.20     149.88  ± 176.28     175.15  ± 208.87     158.01  ± 177.11  
Serum C-Telopeptide (CTx)  
[units: ng/mL]
Mean ± Standard Deviation
  1.12  ± 1.18     1.40  ± 1.93     1.34  ± 1.27     1.28  ± 1.48  
[1] Corrected for urine creatinine (uNTx/Creatinine)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13   [ Time Frame: 13 weeks ]

2.  Secondary:   uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25   [ Time Frame: 25 weeks ]

3.  Secondary:   Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25   [ Time Frame: Baseline, week 25 ]

4.  Secondary:   Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol   [ Time Frame: Day 1, week 25 ]

5.  Secondary:   Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol   [ Time Frame: Day 1, week 25 ]

6.  Secondary:   Percent Change of Serum CTX From Baseline to Week 25   [ Time Frame: Baseline, week 25 ]

7.  Secondary:   Time to First Skeletal Related Event   [ Time Frame: Day 1, week 25 ]

8.  Secondary:   Skeletal Related Events   [ Time Frame: Day 1, week 25 ]

9.  Secondary:   Hypercalcemia   [ Time Frame: Day 1, week 25 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00104650     History of Changes
Obsolete Identifiers: NCT00121342
Other Study ID Numbers: 20040114
Study First Received: March 3, 2005
Results First Received: December 9, 2010
Last Updated: January 20, 2011
Health Authority: Canada: Health Canada
European Union: European Medicines Agency
France: Ministry of Health
Mexico: Ministry of Health
Poland: Drug Institut
United States: Food and Drug Administration
United States: Western Institutional Review Board
Belgium: Pharmaceutical Inspectorate