NCT00430144

Brief Summary

-list item one, The purpose of this study is to evaluate the overall response rate of belotecan (CKD-602) in recurrent or progressive carcinoma of uterine cervix

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

January 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

April 26, 2012

Status Verified

April 1, 2012

Enrollment Period

2.6 years

First QC Date

January 31, 2007

Last Update Submit

April 25, 2012

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • overall response rate of belotecan (CKD-602)

    1 week before the start of Cycle 4, 3 weeks later Cycle 6 or at discontinuation of study treatment, and then at least every 3 months

Study Arms (1)

CKD-602

EXPERIMENTAL
Drug: Belotecan(CKD-602)

Interventions

Belotecan(CKD-602)DRUG

Belotecan was administrated at 0.5 mg/m(2)/day for 5 consecutive days every 3-week cycle

Also known as: Camptobel
CKD-602

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed, patients with recurrent uterine cervical carcinoma who were unsuitable candidates for curative treatment with surgery and/or radiotherapy.
  • One of the following histologic types
  • Squamous cell carcinoma
  • Adenocarcinoma
  • Adenosquamous carcinoma
  • Clinically measurable disease
  • Performance status of 0, 1, 2 on the ECOG criteria

You may not qualify if:

  • Histology of neuroendocrine tumors
  • Patient previously treated with topoisomerase-I inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National cancer center

Seoul, South Korea

Location

Related Publications (1)

  • Hwang JH, Lim MC, Seo SS, Park SY, Kang S. Phase II study of belotecan (CKD 602) as a single agent in patients with recurrent or progressive carcinoma of uterine cervix. Jpn J Clin Oncol. 2011 May;41(5):624-9. doi: 10.1093/jjco/hyr017. Epub 2011 Feb 24.

    PMID: 21355002DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

belotecan

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Sokbom Kang

    National cancer cencer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
director, gynecologic oncology research branch

Study Record Dates

First Submitted

January 31, 2007

First Posted

February 1, 2007

Study Start

January 1, 2007

Primary Completion

August 1, 2009

Study Completion

October 1, 2010

Last Updated

April 26, 2012

Record last verified: 2012-04

Locations

KR(1)