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A Phase IIb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell Inj.) or Topotecan in Patients With Relapsed Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Small Cell Lung Cancer

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Trial Information

A Phase IIb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell Inj.) or Topotecan in Patients With Relapsed Small Cell Lung Cancer


Inclusion Criteria:



- At least 18 years of age

- Histological or cytological diagnosis of SCLC

- Limited disease (LD) or Extensive disease (ED) at time of study entry

- Recurrent or progressive SCLC ≥ 90 days of duration of response for first-line
therapy

- Measurable disease defined by RECIST criteria

- ECOG Performance Status of 0, 1, or 2

- Life expectancy > 3 months

- Adequate bone marrow, Renal, Hepatic reserve:

- absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/μL

- platelet count ≥ 100,000 cells/μL

- hemoglobin ≥ 9 g/dL

- Total bilirubin ≤ 1.5 X ULN

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 X ULN

- Alkaline Phosphatase (ALP) ≤ 2.0 X ULN

- Serum creatinine < 1.5mg/dL or calculated creatinine clearance > 60mL/min

- 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 and Pregnant or nursing women

- Participation in any investigational drug study within 28 days prior to study entry

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Objectives Response Rate

Outcome Time Frame:

up to 18 weeks

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

11SCLC09I

NCT ID:

NCT01497873

Start Date:

September 2010

Completion Date:

February 2014

Related Keywords:

  • Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Belotecan
  • Topotecan
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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