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Phase Ⅱa,Open Label,Multicenter Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

Phase Ⅱa,Open Label,Multicenter Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer


All eligible patients will receive SB injection therapy for 4 cycles (14~21 days for each
cycle). SB injection treatment could be continue after completion of therapy cycles until
6th cycle. It depends on the investigator's decision and patient's will. Efficacy will be
evaluated every two cycles.


Inclusion Criteria:



- Age of 18-70 years

- Patients with histologically or cytologically confirmed Non-Small Cell Lung Cancer

- Patients who had failed more than 1 cycle of standard therapy with advanced or
metasatic stage not available to any of resectable surgery or radiotherapy.

- Patients with measurable lesions

- Eatern Cooperative Oncolgy Group status 0 to 2.

- Life expectancy >/= 5 months

- Patients with adequate organ(heart, kidney, liver)and bone marrow function, as
defined by

1. Absolute neutrophil count >/= 1.5 x 10^9/L, Platelet count >/= 100 x 10^9/L

2. Total bilirubin
3. Aspartate Aminotransferase and/or Alanine Aminotransferase of normal

4. creatinine
- Patients who have signed the informed consent form.

Exclusion Criteria:

- Female volunteers admitted to the study must be using a reliable means of
contraception

- Received radiation therapy within 6 weeks before randomization

- Known brain or spinal cord metastases

- Have acute infection

- Have active infection or serious concomitant systemic disorder incompatible with the
study

- Presence or history of malignancy other than Non-Small Cell Lung Cancer

- Have severe neurologic or psychological disorder

- Patients who have to receive other chemo-radiotherapy or immunotherapy

- Patients who have received chemotherapy within the previous 30 days

- Patients who are candidates for combined modality treatment.

- Patients who have participated in a clinical study within the previous 30 days

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Best Response Rate

Outcome Time Frame:

2.5 months

Safety Issue:

No

Principal Investigator

Jae-yong Park, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kyungpook University Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

SB Injection

NCT ID:

NCT01305967

Start Date:

January 2003

Completion Date:

June 2011

Related Keywords:

  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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