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Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis

Primary Purpose

Non Small Cell Lung Cancer, Bone Metastases, High NTX Level

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
zometa
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring non small cell lung cancer, NTX, zometa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18
  • Histologically confirmed non-small cell cancer
  • One bone metastasis at least confirmed by image(X ray, CT or others)
  • NTX > 50nM BCE/mM creatinine
  • Life expectancy > 6 M
  • ECOG <= 2
  • Signed ICF

Exclusion Criteria:

  • Women who are pregnant or in lactation
  • Patients with hyperostosis with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
  • Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
  • Severe co-morbidity of any type that may interfere with assessment of the patient for the study -

Sites / Locations

  • cancer center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Skeleton-related event

Secondary Outcome Measures

OS

Full Information

First Posted
September 29, 2008
Last Updated
December 8, 2013
Sponsor
Sun Yat-sen University
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00762346
Brief Title
Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis
Official Title
Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A multicenter prospective study to assess the efficacy and safety of ZOMETA® in treatment of high-level NTX non small cell lung cancer with bone metastasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Bone Metastases, High NTX Level
Keywords
non small cell lung cancer, NTX, zometa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
zometa
Intervention Description
zometa 4mg i.v. every 4 weeks for up to 2 years
Primary Outcome Measure Information:
Title
Skeleton-related event
Time Frame
2 years
Secondary Outcome Measure Information:
Title
OS
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 Histologically confirmed non-small cell cancer One bone metastasis at least confirmed by image(X ray, CT or others) NTX > 50nM BCE/mM creatinine Life expectancy > 6 M ECOG <= 2 Signed ICF Exclusion Criteria: Women who are pregnant or in lactation Patients with hyperostosis with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy Severe co-morbidity of any type that may interfere with assessment of the patient for the study -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zhang, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
cancer center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis

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