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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01630018
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : September 22, 2016
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Tracking Information
First Submitted Date  ICMJE March 6, 2012
First Posted Date  ICMJE June 28, 2012
Last Update Posted Date September 22, 2016
Study Start Date  ICMJE January 2011
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2012)
Objective response rate [ Time Frame: approximately 21 days(every 1 Cycle) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2012)
  • Overall Survival [ Time Frame: up to 4 years ]
  • Progression Free survival [ Time Frame: up tp 4 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Belotecan Versus Topotecan for Recurrent Ovarian Cancer: A Randomized, Open-label, Parallel-group Phase IIb Trial
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epithelial Ovarian Cancer
Intervention  ICMJE
  • Drug: Topotecan
    1.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
    Other Name: Hycamtin inj.
  • Drug: Belotecan
    0.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
    Other Name: Camtobell inj.
Study Arms  ICMJE
  • Active Comparator: Topotecan
    Topotecan
    Intervention: Drug: Topotecan
  • Active Comparator: Camtobell
    Belotecan
    Intervention: Drug: Belotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2016)
141
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2012)
140
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01630018
Other Study ID Numbers  ICMJE 11AOC09J
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chong Kun Dang Pharmaceutical
Study Sponsor  ICMJE Chong Kun Dang Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Yong-Sang Song, phD, Dr Seoul National University Hospital
PRS Account Chong Kun Dang Pharmaceutical
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP