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

NCT02101164 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-02-18

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2014-11-30
Completion
2014-11-30

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Entities

Drugs
Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101164 on ClinicalTrials.gov