Evaluate Time Associated With the Preparation & Administration of Denosumab/Pamidronate in Patients With Solid Tumors and Metastatic Bone Disease

Phase 4

Withdrawn

• Conditions: Metastatic Bone Disease; Solid Tumor
• Interventions: Biological: denosumab; Drug: pamidronate

• Registration Number: NCT02101164
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-28
• Study First Posted: 2014-04-02
• Study Start: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-16
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Group B	denosumab	1 dose of pamidronate every 4 weeks for 2 doses, followed by 1 dose of denosumab every 4 weeks for 2 doses.
Treatment Group A	denosumab	1 dose of denosumab every 4 weeks for 2 doses, followed by 1 dose of pamidronate every 4 weeks for 2 doses.
Treatment Group A	pamidronate	1 dose of denosumab every 4 weeks for 2 doses, followed by 1 dose of pamidronate every 4 weeks for 2 doses.
Treatment Group B	pamidronate	1 dose of pamidronate every 4 weeks for 2 doses, followed by 1 dose of denosumab every 4 weeks for 2 doses.

Primary Outcome Measures

Name	Time	Method
Total duration (in hours, minutes and seconds) for investigational product preparation and administration	Week 13