Evaluate Time Associated With the Preparation & Administration of Denosumab/Pamidronate in Patients With Solid Tumors and Metastatic Bone Disease
An Open-Label, Multicentre Trial to Evaluate the Time Associated With the Preparation and Administration of Denosumab and Pamidronate in Subjects With Solid Tumors and Metastatic Bone Disease in Canada
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
This study will estimate the total time for the preparation and administration of denosumab and the total time for the preparation and administration of pamidronate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2014
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
March 12, 2014
CompletedFirst Posted
Study publicly available on registry
April 2, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedFebruary 18, 2015
January 1, 2015
Same day
March 12, 2014
February 16, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Total duration (in hours, minutes and seconds) for investigational product preparation and administration
Day 1
Total duration (in hours, minutes and seconds) for investigational product preparation and administration
Week 5
Total duration (in hours, minutes and seconds) for investigational product preparation and administration
Week 9
Total duration (in hours, minutes and seconds) for investigational product preparation and administration
Week 13
Study Arms (2)
Treatment Group A
ACTIVE COMPARATOR1 dose of denosumab every 4 weeks for 2 doses, followed by 1 dose of pamidronate every 4 weeks for 2 doses.
Treatment Group B
ACTIVE COMPARATOR1 dose of pamidronate every 4 weeks for 2 doses, followed by 1 dose of denosumab every 4 weeks for 2 doses.
Interventions
Treatment Group A - 120 mg SC dose every 4 weeks at Day 1 and week 5 Treatment Group B - 120 mg SC dose every 4 weeks at Week 9 and Week 13
Treatment Group A - 90 mg IV dose every 4 weeks at Week 9 and Week 13 Treatment Group B - 90 mg IV dose every 4 weeks at Day 1 and Week 5
Eligibility Criteria
You may qualify if:
- Diagnosis of metastatic bone disease secondary to a solid tumor (eg, breast cancer, lung cancer, etc).
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subject is one of the following:
- being considered for pamidronate IV infusions or denosumab SC injections for treatment of metastatic bone disease (prescribed per Canadian product monograph); OR
- scheduled to receive pamidronate IV infusions or denosumab SC injections for treatment of metastatic bone disease (prescribed per Canadian product monograph); OR
- currently receiving pamidronate IV infusions or denosumab SC injections for treatment of metastatic bone disease AND has received no more than 4 prior administration of either product combined (prescribed per Canadian product monograph).
- Subject has a serum calcium or albumin-adjusted serum calcium ≥ 2.0 mmol/L (8.0 mg/dL) and ≤ 2.9 mmol/L (11.5 mg/dL)
You may not qualify if:
- Diagnosis with metastatic bone disease secondary to multiple myeloma or prostate cancer.
- Severe renal impairment (creatinine clearance \< 30 mL/min)
- Subject is being considered for ambulatory pamidronate administration using an infuser device (ie, "baby bottle").
- A known active infection with Hepatitis B virus or Hepatitis C virus.
- Subject has known positive results for human immunodeficiency virus (HIV).Subject has a history of other malignancy within the past 5 years, other than:
- Malignancy treated with curative intent and with no known active disease present for ≥ 5 years before enrollment and felt to be at low risk for recurrence by the treating physician
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated cervical carcinoma in situ without evidence of disease
- Adequately treated breast ductal carcinoma in situ without evidence of disease
- Prostatic intraepithelial neoplasia without evidence of prostate cancer
- Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
- Subject has a history or current evidence of osteonecrosis/osteomyelitis of the jaw, active dental or jaw condition that requires oral surgery, non-healed dental/oral surgery, or planned invasive dental procedure over the course of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2014
First Posted
April 2, 2014
Study Start
November 1, 2014
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
February 18, 2015
Record last verified: 2015-01