NCT01840943

Brief Summary

The purpose of this study is to compare the effectiveness between CAELYX and topotecan hydrochloride (HCl) in Chinese participants with recurrent epithelial ovarian carcinoma following failure of first-line, platinum-based chemotherapy, who have received no more than one prior platinum-based regimen therapy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

7 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

March 18, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 23, 2015

Completed
Last Updated

December 23, 2015

Status Verified

November 1, 2015

Enrollment Period

11 months

First QC Date

March 18, 2013

Results QC Date

May 22, 2015

Last Update Submit

November 17, 2015

Conditions

Epithelial Ovarian Cancer

Keywords

Epithelial ovarian cancerRecurrent epithelial ovarian carcinomaCarcinomaMalignancyOvarian carcinomaCAELYXTopotecan hydrochlorideTopotecanPlatinum-based regimen chemotherapyChinese patients

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Progression-free Survival Incidence at Week 24

    Progression-free survival incidence was be measured as number of participants who were progression-free and alive. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Week 24

Secondary Outcomes (14)

  • Duration of Progression-free Survival

    1 year after the last dose (24 weeks) administration

  • Number of Participants With Response

    Up to Week 24

  • Time to Response

    Up to Week 24

  • Duration of Response

    Up to 1 year of last dose (Week 24) administration

  • Health-related Quality of Life Assessment (HQL)

    Day 1 of each cycle of study medication and Week 4 after last dose of study medication

  • +9 more secondary outcomes

Study Arms (2)

CAELYX

EXPERIMENTAL

Participants will receive CAELYX 50 mg per square meter intravenously on Day 1 of each cycle as: 60 to 90-minute infusion to the participants not undergoing pharmacokinetic (PK) evaluation and 90-minute infusion to the participants undergoing PK evaluation.

Drug: CAELYX

Topotecan hydrochloride (HCl)

ACTIVE COMPARATOR

Participants will receive topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.

Drug: Topotecan HCl

Interventions

CAELYXDRUG

CAELYX 50 mg per square meter will be administered intravenously on Day 1 of each cycle as: 60 to 90-minute infusion to the participants not undergoing pharmacokinetic (PK) evaluation and 90-minute infusion to the participants undergoing for PK evaluation.

CAELYX
Topotecan HClDRUG

Topotecan 1.25 mg per square meter per day will be administered, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.

Topotecan hydrochloride (HCl)

Eligibility Criteria

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

You may qualify if:

  • Histological diagnosed with epithelial ovarian carcinoma with measurable disease
  • Recurrent epithelial ovarian carcinoma or disease progression following failure of first-line, platinum-based chemotherapy with no more than one prior platinum based regimen therapy
  • Adequate laboratory values of bone marrow function, renal function, liver function, and echocardiogram tests
  • Agrees to use protocol-defined effective contraception. A woman must agree not to donate eggs (ova, oocytes) for the purpose of assisted reproduction
  • Disease-free from prior malignancies for more than 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

You may not qualify if:

  • Females who are pregnant or breast feeding or planning to become pregnant while enrolled in this study or within 1 year after the last dose of study medication
  • Myocardial infarct within 6 months before enrollment, class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
  • Uncontrolled systemic infection that requires systemic anti-infective treatment
  • Prior therapy with CAELYX or topotecan HCl
  • Prior chemotherapy within 28 days of first dose of study medication (or 42 days if participant has received a nitrosourea or mitomycin)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Beijing, China

Location

Unknown Facility

Changsha, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Jinan, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Nanning, China

Location

Unknown Facility

Wuhan, China

Location

Related Publications (1)

  • Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.

    PMID: 37407274DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialCarcinomaNeoplasmsOvarian Neoplasms

Interventions

liposomal doxorubicinTopotecan

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeEndocrine 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

Limitations and Caveats

The study was terminated early as the total number of participants treated in this study was low and only descriptive analysis was used for efficacy and safety evaluation.

Results Point of Contact

Title
Senior Director Clin Development
Organization
Xian Janssen Pharmaceutical LTD
ClinicalTrialDisclosure@its.jnj.com

Study Officials

  • Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

    Xian-Janssen Pharmaceutical Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2013

First Posted

April 26, 2013

Study Start

June 1, 2013

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

December 23, 2015

Results First Posted

December 23, 2015

Record last verified: 2015-11

Locations

CN(7)