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Belotecan Versus Topotecan for Recurrent Ovarian Cancer: A Randomized, Open-label, Parallel-group Phase IIb Trial

Primary Purpose

Epithelial Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Topotecan
Belotecan
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Epithelial Ovarian Cancer, Belotecan, Topotecan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Topotecan

Camtobell

Arm Description

Topotecan

Belotecan

Outcomes

Primary Outcome Measures

Objective response rate

Secondary Outcome Measures

Overall Survival
Progression Free survival

Full Information

First Posted
March 6, 2012
Last Updated
September 20, 2016
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01630018
Brief Title
Belotecan Versus Topotecan for Recurrent Ovarian Cancer: A Randomized, Open-label, Parallel-group Phase IIb Trial
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer
Keywords
Epithelial Ovarian Cancer, Belotecan, Topotecan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topotecan
Arm Type
Active Comparator
Arm Description
Topotecan
Arm Title
Camtobell
Arm Type
Active Comparator
Arm Description
Belotecan
Intervention Type
Drug
Intervention Name(s)
Topotecan
Other Intervention Name(s)
Hycamtin inj.
Intervention Description
1.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
Intervention Type
Drug
Intervention Name(s)
Belotecan
Other Intervention Name(s)
Camtobell inj.
Intervention Description
0.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
Primary Outcome Measure Information:
Title
Objective response rate
Time Frame
approximately 21 days(every 1 Cycle)
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
up to 4 years
Title
Progression Free survival
Time Frame
up tp 4 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-Sang Song, phD, Dr
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul Metropolitan
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
32994466
Citation
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.
Results Reference
derived

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Belotecan Versus Topotecan for Recurrent Ovarian Cancer: A Randomized, Open-label, Parallel-group Phase IIb Trial

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