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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02101164
• Other study ID #: 20120127
• Status: Withdrawn
• Phase: Phase 4
• First received: March 12, 2014
• Last updated: February 16, 2015
• Start date: November 2014
• Est. completion date: November 2014

Study information

• Verified date: January 2015
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Bone Diseases
• Metastatic Bone Disease
• Solid Tumor

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total duration (in hours, minutes and seconds) for investigational product preparation and administration		Day 1	No
Primary	Total duration (in hours, minutes and seconds) for investigational product preparation and administration		Week 5	No
Primary	Total duration (in hours, minutes and seconds) for investigational product preparation and administration		Week 9	No
Primary	Total duration (in hours, minutes and seconds) for investigational product preparation and administration		Week 13	No

External Links

•   AmgenTrials clinical trials website