NCT01630018

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

3.4 years

First QC Date

March 6, 2012

Last Update Submit

September 20, 2016

Conditions

Epithelial Ovarian Cancer

Keywords

Epithelial Ovarian CancerBelotecanTopotecan

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    approximately 21 days(every 1 Cycle)

Secondary Outcomes (2)

  • Overall Survival

    up to 4 years

  • Progression Free survival

    up tp 4 years

Study Arms (2)

Topotecan

ACTIVE COMPARATOR

Topotecan

Drug: Topotecan

Camtobell

ACTIVE COMPARATOR

Belotecan

Drug: Belotecan

Interventions

TopotecanDRUG

1.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression

Also known as: Hycamtin inj.
Topotecan
BelotecanDRUG

0.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression

Also known as: Camtobell inj.
Camtobell

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul Metropolitan, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 32994466DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Topotecanbelotecan

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Yong-Sang Song, phD, Dr

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2012

First Posted

June 28, 2012

Study Start

January 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

KR(1)