Cervical CancerPhase 2NCT00430144
Belotecan (CKD-602) in Recurrent or Progressive Carcinoma of Uterine Cervix
A Phase 2 study testing Belotecan(CKD-602) in people with Cervical Cancer, run by Sokbom Kang at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Belotecan(CKD-602)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2007to Oct 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Histology of neuroendocrine tumors
- Patient previously treated with topoisomerase-I inhibitor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Belotecan (CKD-602) in Recurrent or Progressive Carcinoma of Uterine Cervix
-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
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Belotecan(CKD-602)
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belotecan(CKD-602)Drug
Also called Camptobel
Belotecan was administrated at 0.5 mg/m(2)/day for 5 consecutive days every 3-week cycle
| Study group | Role | What they receive |
|---|---|---|
| CKD-602 | Experimental | Not described Receives: Drug: Belotecan(CKD-602) |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate of belotecan (CKD-602)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionAug 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sokbom Kang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Sokbom Kang, National Cancer Center, Korea
- Investigators
- Sokbom Kang, Principal investigator, National cancer cencer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430144
- Sponsor's protocol ID
- NCCCTS-06-214
- Status last verified
- Apr 2012
- First submitted
- 31 Jan 2007
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21355002
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Belotecan (CKD-602) in Recurrent or Progressive Carcinoma of Uterine Cervix
- ClinicalTrials.gov ID
- NCT00430144
- Acronym / sponsor ID
- NCCCTS-06-214
- Conditions
- Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sokbom KangOther government
- Study start
- Jan 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 1 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
-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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD-602 | Experimental | Drug: Belotecan(CKD-602) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Histology of neuroendocrine tumors
- Patient previously treated with topoisomerase-I inhibitor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belotecan(CKD-602)Also: CamptobelBelotecan was administrated at 0.5 mg/m(2)/day for 5 consecutive days every 3-week cycle | Drug | CKD-602 |
Primary outcome
overall response rate of belotecan (CKD-602)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2012.
- Derived from this study: PubMed 21355002Hwang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sokbom Kang principal investigator
National cancer cencer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Belotecan(CKD-602) in people with Cervical Cancer, run by Sokbom Kang at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate of belotecan (CKD-602) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00430144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2012.