Small Cell Lung CancerPhase 1/2NCT01784107
A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer
A Phase 1/2 study testing Belotecan and Ifosfamide in people with Small Cell Lung Cancer, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
Phase 1 : To evaluate MTD(Maximal tolerated dose)and DLT(Dose limiting Toxicity) of Belotecan and Ifosfamide. Phase 2 : To analyse efficacy and toxicity of Belotecan and Ifosfamide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Belotecan and Ifosfamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Jul 2018
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically or cytologically confirmed extensive disease of Small cell lung cancer
- no prior chemotherapy or radiotherapy for lung
- measurable lesion for RECIST
- over 18 years
- ECOG 0~2
- expected life span more than 3 months
Who cannot join
- acute or active infection
- uncontrolled cerebral nerve symptoms or metastasis
- significant myocardial infarction or cardiac disease within 12 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gachon University Gil Medical Center
Incheon
Hee Kyung Ahn, +82-32-460-3229, hkahn@gilhospital.com
About this study
Phase 1 : To evaluate MTD(Maximal tolerated dose)and DLT(Dose limiting Toxicity) of Belotecan and Ifosfamide.
Phase 2 : To analyse efficacy and toxicity of Belotecan and Ifosfamide.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Belotecan and Ifosfamide
- Keywords
- SCLC, belotecan, Ifosfamide
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belotecan and IfosfamideDrug
| Study group | Role | What they receive |
|---|---|---|
| Belotecan and Ifosfamide | Experimental | Not described Receives: Drug: Belotecan and Ifosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD (maximal tolerated dose)
Measured: one year
Secondary outcomes (1)
DLT(dose-limiting toxicity)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startJul 2011
- Primary completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Kyung Cho, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784107
- Sponsor's protocol ID
- 2011-GIRBA-2550
- Status last verified
- Feb 2016
- First submitted
- 30 Jan 2013
- Last updated
- 10 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01784107
- Acronym / sponsor ID
- 2011-GIRBA-2550
- Conditions
- Small Cell Lung Cancer
- Keywords
- SCLC, belotecan, Ifosfamide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2018 (estimated)
- First posted
- 5 Feb 2013 (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.
Phase 1 : To evaluate MTD(Maximal tolerated dose)and DLT(Dose limiting Toxicity) of Belotecan and Ifosfamide.
Phase 2 : To analyse efficacy and toxicity of Belotecan and Ifosfamide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Belotecan and Ifosfamide | Experimental | Drug: Belotecan and Ifosfamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- histologically or cytologically confirmed extensive disease of Small cell lung cancer
- no prior chemotherapy or radiotherapy for lung
- measurable lesion for RECIST
- over 18 years
- ECOG 0~2
Key exclusion criteria (3 listed)
- acute or active infection
- uncontrolled cerebral nerve symptoms or metastasis
- significant myocardial infarction or cardiac disease within 12 months
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 and Ifosfamide | Drug | Belotecan and Ifosfamide |
Primary outcome
MTD (maximal tolerated dose)
Time frame: one year
1 secondary outcome
DLT(dose-limiting toxicity)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Belotecan and Ifosfamide in people with Small Cell Lung Cancer, run by Gachon University Gil Medical Center 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Feb 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee Kyung Ahn (+82-32-460-3229, hkahn@gilhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (maximal tolerated dose) (time frame: one year). 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 10 Feb 2016.