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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022671
• Other study ID #: 11NSCLC08K
• Status: Completed
• Phase: Phase 2
• First received: November 26, 2009
• Last updated: January 27, 2016
• Start date: September 2009
• Est. completion date: March 2010

Study information

• Verified date: January 2016
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

A phase II study is conducted to determine the efficacy and safety of a single agent Camtobell inj.(belotecan) on a weekly schedule in locally advanced or metastatic non-small cell lung cancer patients previously treated with chemotherapy. The usefulness of the this regimen is evaluated by response rate, median survival time, progression free survival and duration of response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Belotecan
3.0 mg/m2, Day 1, 8, 15 every 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical	Asan Medical Center, Samsung Medical Center, Seoul National University Hospital, Ulsan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate		every 2 cyc	No
Secondary	Overall Survival		6 months after Last patient out	No
Secondary	Progression Free survival		6 months after Last patient out	No
Secondary	Adverse event		every visit	Yes