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Trial record 2 of 740 for:    Open Studies | "Bone Diseases"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02101164
First received: March 12, 2014
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Solid Tumor
Metastatic Bone Disease
Biological: denosumab
Drug: pamidronate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Total duration (in hours, minutes and seconds) for investigational product preparation and administration [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Total duration (in hours, minutes and seconds) for investigational product preparation and administration [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
  • Total duration (in hours, minutes and seconds) for investigational product preparation and administration [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
  • Total duration (in hours, minutes and seconds) for investigational product preparation and administration [ Time Frame: Week 13 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 - 1-120 mg SC dose every 4 weeks at Day 1 and week 5 Treatment Group B - 1-120 mg SC dose every 4 weeks at Week 9 and Week 13
Other Name: XGEVA
Drug: pamidronate
Treatment Group A - 1-90 mg IV dose every 4 weeks at Week 9 and Week 13 Treatment Group B - 1-90 mg IV dose every 4 weeks at Day 1 and Week 5
Other Name: 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 - 1-120 mg SC dose every 4 weeks at Day 1 and week 5 Treatment Group B - 1-120 mg SC dose every 4 weeks at Week 9 and Week 13
Other Name: XGEVA
Drug: pamidronate
Treatment Group A - 1-90 mg IV dose every 4 weeks at Week 9 and Week 13 Treatment Group B - 1-90 mg IV dose every 4 weeks at Day 1 and Week 5
Other Name: Aredia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02101164

Contacts
Contact: Amgen Call Center 866-572-6436

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02101164     History of Changes
Other Study ID Numbers: 20120127
Study First Received: March 12, 2014
Last Updated: August 7, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Bone Diseases
Neoplasms
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 25, 2014