NCT01022671

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

November 26, 2009

Last Update Submit

January 27, 2016

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

BelotecanCamtobell injNSCLC

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    every 2 cyc

Secondary Outcomes (3)

  • Overall Survival

    6 months after Last patient out

  • Progression Free survival

    6 months after Last patient out

  • Adverse event

    every visit

Study Arms (1)

Belotecan

EXPERIMENTAL

Single arm

Drug: Belotecan

Interventions

BelotecanDRUG

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

Also known as: Camtobell inj.
Belotecan

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

belotecan

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2009

First Posted

December 1, 2009

Study Start

September 1, 2009

Primary Completion

February 1, 2010

Study Completion

March 1, 2010

Last Updated

January 28, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share