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

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Solid Tumor; Metastatic Bone Disease

Intervention: denosumab (Biological); pamidronate (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Total duration (in hours, minutes and seconds) for investigational product preparation and administration

Total duration (in hours, minutes and seconds) for investigational product preparation and administration

Total duration (in hours, minutes and seconds) for investigational product preparation and administration

Total duration (in hours, minutes and seconds) for investigational product preparation and administration

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Starting date: November 2014
Last updated: February 16, 2015

Page last updated: August 23, 2015

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