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

• Sponsor: Chong Kun Dang Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01022671
• Collaborator: Asan Medical Center (Other), Samsung Medical Center (Other), Seoul National University Hospital (Other), Ulsan University Hospital (Other)
• Enrollment: 52
• Arm: 1
• Duration (Months): 5.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Belotecan	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Belotecan Single arm	Drug: Belotecan; 3.0 mg/m2, Day 1, 8, 15 every 4 weeks; Other Names: Camtobell inj.

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate [every 2 cyc]

Secondary Outcome Measures

1. Overall Survival [6 months after Last patient out]

2. Progression Free survival [6 months after Last patient out]

3. Adverse event [every visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Chong Kun Dang Pharmaceutical
• Asan Medical Center
• Samsung Medical Center
• Seoul National University Hospital
• Ulsan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT01022671
• Other Study ID Numbers: 11NSCLC08K
• First Posted: Dec 1, 2009
• Last Update Posted: Jan 28, 2016
• Last Verified: Jan 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Chong Kun Dang Pharmaceutical: Belotecan; Camtobell inj; NSCLC
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung; Belotecan

Study Results

No Results Posted as of Jan 28, 2016