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

NCT ID: NCT00762346

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non Small Cell Lung Cancer Bone Metastases High NTX Level

Keywords

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non small cell lung cancer NTX zometa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

zometa

Intervention Type DRUG

zometa 4mg i.v. every 4 weeks for up to 2 years

Interventions

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zometa

zometa 4mg i.v. every 4 weeks for up to 2 years

Intervention Type DRUG

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Li Zhang

Profressor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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cancer center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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CZOL446ECN06T

Identifier Type: -

Identifier Source: org_study_id