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

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.

Study Overview

• Status: Withdrawn
• Conditions: Solid Tumor; Metastatic Bone Disease
• Intervention / Treatment: Biological: denosumab; Drug: pamidronate

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment Group A; 1 dose of denosumab every 4 weeks for 2 doses, followed by 1 dose of pamidronate every 4 weeks for 2 doses.	Biological: denosumab; 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; Other Names: XGEVA; Drug: pamidronate; 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; Other Names: Aredia
Active Comparator: Treatment Group B; 1 dose of pamidronate every 4 weeks for 2 doses, followed by 1 dose of denosumab every 4 weeks for 2 doses.	Biological: denosumab; 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; Other Names: XGEVA; Drug: pamidronate; 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; Other Names: Aredia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: March 12, 2014
• First Submitted That Met QC Criteria: March 28, 2014
• First Posted (Estimate): April 2, 2014

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 16, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Physiological Effects of Drugs; Bone Density Conservation Agents; Denosumab; Pamidronate
• Other Study ID Numbers: 20120127