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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01022671

Enrollment

Registered

2009-12-01

Start date

2009-09-30

Completion date

2010-03-31

Last updated

2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Belotecan, Camtobell inj, NSCLC

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.

Interventions

DRUGBelotecan

3.0 mg/m2, Day 1, 8, 15 every 4 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Objective Response Rate	every 2 cyc

Secondary

Measure	Time frame
Overall Survival	6 months after Last patient out
Progression Free survival	6 months after Last patient out
Adverse event	every visit

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026