Epithelial Ovarian CancerPhase 2NCT01630018
Belotecan Versus Topotecan for Recurrent Ovarian Cancer: A Randomized, Open-label, Parallel-group Phase IIb Trial
A Phase 2 study testing Topotecan and Belotecan in people with Epithelial Ovarian Cancer, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the efficacy and safety of belotecan or topotecan in patients with recurrent or refractory ovarian cancer (AOC). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Topotecan and Belotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Jun 2014
- 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
- At least 18 years of age
- Histological or cytological diagnosis of AOC
- Stable disease (SD) or progression at time of study entry Recurrent or progressive AOC ≥ 90 days of duration of response for first-line therapy
- Measurable disease defined by RECIST criteria
- ECOG Performance Status of 0, 1, or 2
- Life expectancy > 3 months
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- Adequate bone marrow, Renal, Hepatic reserve:
- absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/μL
- platelet count ≥ 100,000 cells/μL
- hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 X ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 X ULN
- Alkaline Phosphatase (ALP) ≤ 2.0 X ULN
- Serum creatinine < 1.5mg/dL or calculated creatinine clearance > 60mL/min
- Signed a written informed consent
Who cannot join
- 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 and Pregnant or nursing women
- Participation in any investigational drug study within 28 days prior to study entry
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul Metropolitan
About this study
Official title: A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell Inj.) or Topotecan in Patients With Recurrent or Refractory Ovarian Cancer
The purpose of this study is to determine the efficacy and safety of belotecan or topotecan in patients with recurrent or refractory ovarian cancer (AOC).
Read the detailed description
A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan (CamtoBell inj.) or Topotecan in Patients with Recurrent or Refractory Ovarian Cancer
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Topotecan, Belotecan
- Keywords
- Epithelial Ovarian Cancer, Belotecan, Topotecan
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopotecanDrug
Also called Hycamtin inj.
1.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
BelotecanDrug
Also called Camtobell inj.
0.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
| Study group | Role | What they receive |
|---|---|---|
| Topotecan | Active comparator | Topotecan Receives: Drug: Topotecan |
| Camtobell | Active comparator | Belotecan Receives: Drug: Belotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: approximately 21 days(every 1 Cycle)
Secondary outcomes (2)
Overall Survival
Measured: up to 4 years
Progression Free survival
Measured: up tp 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJan 2011
- Primary completionJun 2014
- Study completionJun 2014
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 Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong-Sang Song, phD, Dr, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630018
- Sponsor's protocol ID
- 11AOC09J
- Status last verified
- Sep 2016
- First submitted
- 6 Mar 2012
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim HS, Park SY, Park CY, Kim YT, Kim BJ, Song YJ, Kim BG, Kim YB, Cho CH, Kim JH, Song YS. A multicentre, randomised, open-label, parallel-group Phase 2b study of belotecan versus topotecan for recurrent ovarian cancer. Br J Cancer. 2021 Jan;124(2):375-382. doi: 10.1038/s41416-020-01098-8. Epub 2020 Sep 30.
PubMed 32994466
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell Inj.) or Topotecan in Patients With Recurrent or Refractory Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01630018
- Acronym / sponsor ID
- 11AOC09J
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- Epithelial Ovarian Cancer, Belotecan, Topotecan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Jun 2012 (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.
The purpose of this study is to determine the efficacy and safety of belotecan or topotecan in patients with recurrent or refractory ovarian cancer (AOC).
Detailed description
A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan (CamtoBell inj.) or Topotecan in Patients with Recurrent or Refractory Ovarian Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topotecan | Active comparator | Drug: TopotecanTopotecan |
| Camtobell | Active comparator | Drug: BelotecanBelotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- At least 18 years of age
- Histological or cytological diagnosis of AOC
- Stable disease (SD) or progression at time of study entry Recurrent or progressive AOC ≥ 90 days of duration of response for first-line therapy
- Measurable disease defined by RECIST criteria
- ECOG Performance Status of 0, 1, or 2
Key exclusion criteria (6 listed)
- 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 and Pregnant or nursing women
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 |
|---|---|---|
| TopotecanAlso: Hycamtin inj.1.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression | Drug | Topotecan |
| BelotecanAlso: Camtobell inj.0.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression | Drug | Camtobell |
Primary outcome
Objective response rate
Time frame: approximately 21 days(every 1 Cycle)
2 secondary outcomes
Overall Survival
Time frame: up to 4 years
Progression Free survival
Time frame: up tp 4 years
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 22 Sep 2016.
- Derived from this study: PubMed 32994466Kim HS, Park SY, Park CY, Kim YT, Kim BJ, Song YJ, Kim BG, Kim YB, Cho CH, Kim JH, Song YS. A multicentre, randomised, open-label, parallel-group Phase 2b study of belotecan versus topotecan for recurrent ovarian cancer. Br J Cancer. 2021 Jan;124(2):375-382. doi: 10.1038/s41416-020-01098-8. Epub 2020 Sep 30.
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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.
Yong-Sang Song, phD, Dr study chair
Seoul National University Hospital
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 Topotecan and Belotecan in people with Epithelial Ovarian Cancer, run by Chong Kun Dang Pharmaceutical 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 15 inclusion and 6 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 22 Sep 2016. 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?
Objective response rate (time frame: approximately 21 days(every 1 Cycle)). 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 NCT01630018, 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 22 Sep 2016.