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Efficacy and Safety of Belotecan or Topotecan in Patients With Recurrent or Refractory Ovarian Cancer (AOC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Chong Kun Dang Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01630018
First received: March 6, 2012
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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).


Condition Intervention Phase
Epithelial Ovarian Cancer
Drug: Topotecan
Drug: Belotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: approximately 21 days(every 1 Cycle) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Progression Free survival [ Time Frame: up tp 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Topotecan
Topotecan
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.
Active Comparator: Camtobell
Belotecan
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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630018

Contacts
Contact: Yong-Sang Song, phD, Dr 82-2-2073-2822 yssong@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Seoul Metropolitan, Korea, Republic of
Contact: Yong-Sang Song, phD, Dr    82-2-2072-2822    yssong@snu.ac.kr   
Principal Investigator: Yong-Sang Song, phD, Dr         
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Study Chair: Yong-Sang Song, phD, Dr Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01630018     History of Changes
Other Study ID Numbers: 11AOC09J
Study First Received: March 6, 2012
Last Updated: September 3, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
Epithelial Ovarian Cancer
Belotecan
Topotecan

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Belotecan
Topotecan
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 19, 2014