Clinical trial NCT02101164: Evaluate Time Associated With the Preparation & Administration of Denosumab/Pamidronate in Patients With Solid Tumors and Metastatic Bone Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Solid Tumor
Metastatic Bone Disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-04-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total duration (in hours, minutes and seconds) for investigational product preparation and administration
timeFrame: Day 1
measure: Total duration (in hours, minutes and seconds) for investigational product preparation and administration
timeFrame: Week 5
measure: Total duration (in hours, minutes and seconds) for investigational product preparation and administration
timeFrame: Week 9
measure: Total duration (in hours, minutes and seconds) for investigational product preparation and administration
timeFrame: Week 13
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: