Study of Camtobell Inj (Belotecan) on Weekly Schedule in Non-small Cell Lung Cancer (NSCLC) Patients Previously Treated With Chemotherapy

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01022671
• Date of registration: 26/11/2009
• Primary sponsor: Chong Kun Dang Pharmaceutical
• Public title: Study of Camtobell Inj (Belotecan) on Weekly Schedule in Non-small Cell Lung Cancer (NSCLC) Patients Previously Treated With Chemotherapy
• Scientific title: 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
• Date of first enrolment: September 2009
• Target sample size: 52
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01022671
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Key inclusion & exclusion criteria

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



Age minimum: 19 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Carcinoma, Non-Small-Cell Lung

Intervention(s)

Drug: Belotecan

Primary Outcome(s)

Objective Response Rate [Time Frame: every 2 cyc]

Secondary Outcome(s)

Adverse event [Time Frame: every visit]

Overall Survival [Time Frame: 6 months after Last patient out]

Progression Free survival [Time Frame: 6 months after Last patient out]

Secondary ID(s)

11NSCLC08K

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Asan Medical Center

Samsung Medical Center

Seoul National University Hospital

Ulsan University Hospital