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Single-Arm, Open-label, Multicenter, Phase 2 Clinical Trial to Assess the Efficacy and Safety of Single-Agent Camtobell Inj.(Belotecan) Administered on A Weekly Schedule in Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Previously Treated With Chemotherapy


Phase 2
19 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

Single-Arm, Open-label, Multicenter, Phase 2 Clinical Trial to Assess the Efficacy and Safety of Single-Agent Camtobell Inj.(Belotecan) Administered on A Weekly Schedule in Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Previously Treated With Chemotherapy


Inclusion Criteria:



- 19 Years and older

- Histologically or cytologically confirmed locally advanced or metastatic NSCLC(Stage
IIIB or IV)

- ≥ one measureable or evaluable lesion, <25% of the bone marrow had been irradiated

- prior platinum based chemotherapy

- ECOG PS ≤ 2

- Life expectancy > 3 months

- Adequate organ function:

- hematology: ANC ≥ 1.5×109/L, Platelet ≥ 100×109/L, hemoglobin ≥ 9.0g/dL

- hepatic: total bilirubin ≤ 1.5×ULN, AST/ALT ≤ 2.0×ULN, ALP ≤2.0×ULN

- renal: serum creatinine ≤ 1.5×ULN

- Signed a written informed consent

Exclusion Criteria:

- Active infection

- Symptomatic brain lesion

- Any other type of cancer during the previous 5 years except appropriately treated
basal cell carcinoma of the skin or in situ carcinoma of the cervix

- Severe concurrent diseases

- Prior anticancer therapy within 4 weeks before enroll

- Active pregnancy test

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective Response Rate

Outcome Time Frame:

every 2 cyc

Safety Issue:

No

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

11NSCLC08K

NCT ID:

NCT01022671

Start Date:

September 2009

Completion Date:

March 2010

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Belotecan
  • Camtobell inj
  • NSCLC
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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