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Small Cell Lung CancerPhase 2NCT01497873

A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer

A Phase 2 study testing Topotecan and Belotecan in people with Small Cell Lung Cancer, run by Chong Kun Dang Pharmaceutical at 14 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5 days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung cancer. 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?
Topotecan and Belotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
14 sitesSouth Korea
Study dates
Sep 2010to Mar 2018
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age
  • Histological or cytological diagnosis of SCLC
  • Limited disease (LD) or Extensive disease (ED) at time of study entry
  • Recurrent or progressive SCLC ≥ 90 days of duration of response for firstline therapy
  • Measurable disease defined by RECIST criteria
  • ECOG Performance Status of 0, 1, or 2
Show all 10Show fewer
  • Life expectancy ≥ 3 months
  • Adequate bone marrow, Renal, Hepatic reserve:
  • absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/mm3 platelet count ≥ 100,000 cells/ mm3 hemoglobin ≥ 9 g/dL Total bilirubin ≤ 1.5 mm3 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
  • 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

14 sites in 1 country.

14 sites in 1 country

South Korea14 sites

  • Chungbuk University Hospital

    Daegu

  • Keimyung University Dongsan Center

    Daegu

  • National Cancer Center

    Goyang, 410-769

  • Asan Medical Center

    Seoul

  • CHA Bundang Medical Center

    Seoul

  • Chung-Ang University hospital

    Seoul

  • Kyung Hee University Medical Hospital

    Seoul

  • Seoul National University Boramae Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Seoul St. Marys Hospital

    Seoul

  • Seoul Veterans Hospital

    Seoul

  • Yonsei Cancer Center

    Seoul

  • Ajou University Hospital

    Suwon

  • St. Vincents Hospital

    Suwon

Other trials in South Korea

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 Relapsed Small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5 days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung cancer.

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 Relapsed Small Cell Lung Cancer

Being tested
Topotecan, Belotecan
Keywords
Small Cell Lung Cancer, Belotecan, Topotecan
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.

  • TopotecanDrug

    Also called Hycamtin Injection

    1.5 mg/m^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more

  • BelotecanDrug

    Also called Camtobell Injection

    0.5 mg/m^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more

Study groups in NCT01497873
Study groupRoleWhat they receive
BelotecanExperimentalCamtobell Injection
Receives: Drug: Belotecan
TopotecanActive comparatorHycamtin Injection
Receives: Drug: Topotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objectives Response Rate(ORR, %)

    The response rate was defined as the test subject who had a complete response (CR) or a partial response (PR) as determined by the 'tumor response evaluation' criteria specified in the research protocol

    Measured: Up to 18weeks

Secondary outcomes (2)

  1. Overall Survival(OS)

    Defined as the time from the randomization to the time of death.

    Measured: 7years

  2. Progression Free survival(PFS)

    Defined as the elapsed time from the time of randomization to the time of confirmation of progression or the time of death

    Measured: Up to 18weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2011 (estimated)
  2. Study startSep 2010
  3. Primary completionDec 2017
  4. Study completionMar 2018

Resources

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
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01497873
Sponsor's protocol ID
11SCLC09I
Status last verified
Dec 2018
First submitted
20 Apr 2011
Last updated
27 Dec 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Kang JH, Lee KH, Kim DW, Kim SW, Kim HR, Kim JH, Choi JH, An HJ, Kim JS, Jang JS, Kim BS, Kim HT. A randomised phase 2b study comparing the efficacy and safety of belotecan vs. topotecan as monotherapy for sensitive-relapsed small-cell lung cancer. Br J Cancer. 2021 Feb;124(4):713-720. doi: 10.1038/s41416-020-01055-5. Epub 2020 Nov 16.

    PubMed 33191408

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Topotecan and Belotecan in people with Small Cell Lung Cancer, run by Chong Kun Dang Pharmaceutical at 14 sites 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 10 inclusion and 7 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 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites 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?

Objectives Response Rate(ORR, %) (time frame: Up to 18weeks). 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 NCT01497873, 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 27 Dec 2018.

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