Clinical trial NCT01305967: Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lead sponsor: SBPharmaceutical IND, Co., LTD
Sponsor class: INDUSTRY
First posted: 2011-03-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine efficacy of SB injection in Non Small Cell Lung Cancer.

Detailed description: 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.

Eligibility criteria: 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 \</= upper limit of normal
  3. Aspartate Aminotransferase and/or Alanine Aminotransferase \</= 2 x upeer limit of normal
  4. creatinine \</= 1.5 x upeer limit of normal
* 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

Primary outcomes:
measure: Overall Best Response Rate
timeFrame: 2.5 months
Secondary outcomes:
measure: Determine duration of response rate by measuring time to progression
timeFrame: 2.5 months
measure: Pain Scores on the Visual Analog Scale
timeFrame: 2.5months
measure: Evalute patient's performance by measuring the Eastern Cooperative Oncology Group scale
timeFrame: 2.5months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
state: Jung-gu
city: Deagu
country: Korea, Republic of
facility: Kyungpook University Hospital
state: Jung-gu
city: Anyang
country: Korea, Republic of
facility: Sam Anyang Medical Center
state: Man-an-gu
Study officials:
affiliation: Kyungpook University Hospital
name: Jae-yong Park, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Keimyung University Dongsan Medical Center
name: Seung-beom Han, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Anyang Sam Medical Center
name: Chae-young Lee, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References: