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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer, Bone Metastases, High NTX Level

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Trial Information

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


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 -

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Skeleton-related event

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Li Zhang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Food and Drug Administration

Study ID:

CZOL446ECN06T

NCT ID:

NCT00762346

Start Date:

September 2008

Completion Date:

August 2012

Related Keywords:

  • Non Small Cell Lung Cancer
  • Bone Metastases
  • High NTX Level
  • non small cell lung cancer
  • NTX
  • zometa
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Bone Neoplasms
  • Bone Marrow Diseases

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