Clincosm LogoSign in Get a demo

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

Sponsor
Amgen (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02101164
Collaborator
(none)
0
Enrollment
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
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 Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total duration (in hours, minutes and seconds) for investigational product preparation and administration [Day 1]

    2. Total duration (in hours, minutes and seconds) for investigational product preparation and administration [Week 5]

    3. Total duration (in hours, minutes and seconds) for investigational product preparation and administration [Week 9]

    4. Total duration (in hours, minutes and seconds) for investigational product preparation and administration [Week 13]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT02101164
    Other Study ID Numbers:
    • 20120127
    First Posted:
    Apr 2, 2014
    Last Update Posted:
    Feb 18, 2015
    Last Verified:
    Jan 1, 2015
    Additional relevant MeSH terms:
    Bone Diseases
    Denosumab
    Pamidronate

    Study Results

    No Results Posted as of Feb 18, 2015