Belotecan (CKD-602) in Recurrent or Progressive Carcinoma... | NCT00430144

Studies
Belotecan (CKD-602) in Recurrent or Progressive Carcinoma of Uterine Cervix

NCT00430144

Sponsor

Sokbom Kang

Status

Completed

Last Update Posted

Apr 26, 2012Estimated

Enrollment

16Actual

Phase

Phase 2

Conditions

Cervical Cancer

Interventions

Belotecan(CKD-602)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Aug 2009Actual

Completion Date

Oct 2010Actual

First Submitted Date

Jan 31, 2007

First Submission Date that Met QC Criteria

Jan 31, 2007

First Posted Date

Feb 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2012

Last Update Posted Date

Apr 26, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sokbom Kang, director, gynecologic oncology research branch, National Cancer Center, KoreaSponsor-Investigator

Lead Sponsor

Sokbom KangOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

list item one, to evaluate toxicities of Belotecan
list item two, to evaluate duration of primary response for responding patients
list item three, to evaluate time to disease progression
list item four, to evaluate progression free survival and overall survival.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CKD-602	Experimental		Drug: Belotecan(CKD-602)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Belotecan(CKD-602)	Drug	Belotecan was administrated at 0.5 mg/m(2)/day for 5 consecutive days every 3-week cycle	CKD-602

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sokbom Kang	National cancer cencer	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National cancer center		Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21355002	Derived	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.

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site