Carcinoma, Non-Small-Cell LungPhase 2NCT01022671
Study of Camtobell Inj (Belotecan) on Weekly Schedule in Non-small Cell Lung Cancer (NSCLC) Patients Previously Treated With Chemotherapy
A Phase 2 study testing Belotecan in people with Carcinoma, Non-Small-Cell Lung, run by Chong Kun Dang Pharmaceutical.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Belotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Mar 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 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
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- 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
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
About this study
Official title: Single-Arm, Open-label, Multicenter, Phase 2 Clinical Trial to Assess the Efficacy and Safety of Single-Agent Camtobell Inj.(Belotecan) Administered on A Weekly Schedule in Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Previously Treated With Chemotherapy
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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Belotecan
- Keywords
- Belotecan, Camtobell inj, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelotecanDrug
Also called Camtobell inj.
3.0 mg/m2, Day 1, 8, 15 every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Belotecan | Experimental | Single arm Receives: Drug: Belotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: every 2 cyc
Secondary outcomes (3)
Overall Survival
Measured: 6 months after Last patient out
Progression Free survival
Measured: 6 months after Last patient out
Adverse event
Measured: every visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center, Samsung Medical Center, Seoul National University Hospital, Ulsan University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022671
- Sponsor's protocol ID
- 11NSCLC08K
- Status last verified
- Jan 2016
- First submitted
- 26 Nov 2009
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Arm, Open-label, Multicenter, Phase 2 Clinical Trial to Assess the Efficacy and Safety of Single-Agent Camtobell Inj.(Belotecan) Administered on A Weekly Schedule in Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Previously Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT01022671
- Acronym / sponsor ID
- 11NSCLC08K
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Belotecan, Camtobell inj, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center, Samsung Medical Center, Seoul National University Hospital, Ulsan University Hospital
- Study start
- Sep 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 1 Dec 2009 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Belotecan | Experimental | Drug: BelotecanSingle arm |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 19 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
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
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 |
|---|---|---|
| BelotecanAlso: Camtobell inj.3.0 mg/m2, Day 1, 8, 15 every 4 weeks | Drug | Belotecan |
Primary outcome
Objective Response Rate
Time frame: every 2 cyc
3 secondary outcomes
Overall Survival
Time frame: 6 months after Last patient out
Progression Free survival
Time frame: 6 months after Last patient out
Adverse event
Time frame: every visit
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 28 Jan 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Belotecan in people with Carcinoma, Non-Small-Cell Lung, run by Chong Kun Dang Pharmaceutical.
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 11 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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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: every 2 cyc). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2016; AzTrials last refreshed its copy on 8 Nov 2026.