An Observational Study of Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer (Renaissance)

February 23, 2018 updated by: Suriya Yessentayeva

A Non-interventional, Multicenter Study of the Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer

This is a Non-interventional, Multicenter study evaluating the efficacy and safety of the combination of pegylated liposomal doxorubicin and trabectedin in routine practice in patients with recurrent partial-platinum sensitive ovarian cancer, which is held in Kazakhstan.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Kazakhstan
      • Almaty, Kazakhstan
        • Recruiting
        • Almaty oncological center
        • Contact:
        • Principal Investigator:
          • Rinat Baituganov, PhD
      • Almaty, Kazakhstan
        • Recruiting
        • Almaty regional oncological dispensary
        • Contact:
        • Principal Investigator:
          • Sayakhat Olzhaev, PhD
      • Almaty, Kazakhstan
        • Recruiting
        • Kazakh Institute of Oncology and Radiology
        • Contact:
        • Principal Investigator:
          • Oxana Shatkovskaya, PhD
      • Astana, Kazakhstan
        • Recruiting
        • Astana Oncology Center
        • Contact:
          • Mukhtar Tuleutaev, PhD
          • Phone Number: +77172560073
        • Principal Investigator:
          • Mukhtar Tuleutaev, PhD
      • Kyzylorda, Kazakhstan
        • Recruiting
        • Kyzylorda regional Oncological center
        • Contact:
        • Principal Investigator:
          • Saken Sergaziyev, PhD
      • Oral, Kazakhstan
        • Recruiting
        • West Kazakhstan regional oncology dispensary
        • Contact:
          • Esengeldy Rabaev, PhD
        • Principal Investigator:
          • Esengeldy Rabaev, PhD
      • Petropavlovsk, Kazakhstan
        • Recruiting
        • North Kazakhstan Regional Oncology Center
        • Contact:
        • Principal Investigator:
          • Ermek Abdrimov, PhD
      • Shymkent, Kazakhstan
        • Recruiting
        • South Kazakhstan regional oncologic dispensary
        • Contact:
        • Principal Investigator:
          • Dauranbek Arybzhanov, ЗрВ
      • Ust-Kamenogorsk, Kazakhstan
        • Recruiting
        • East Kazakhstan Regional Oncology Dispensary
        • Contact:
        • Principal Investigator:
          • Gulmira Sagidullina, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with relapsed ovarian cancer

Description

Inclusion Criteria:

  • Age>18
  • Histologically proven epithelial ovarian cancer
  • ECOG 0-1
  • Partially platinum sensitive relapsed ovarian cancer: platinum-free interval 6 -12 months
  • With 1-2 or more cycles on trabectedin treatment at the recommended dose of 1.1mg/m2 q3w 3hr infusion in combination of PLD at 30mg/ml with appropriate pre-medication
  • Prior treatment with 1 or more chemotherapy regimen

Exclusion Criteria:

  • Platinum resistant disease: PFI < 6 months (progression within six months after first-line platinum-based chemotherapy)
  • Unwilling or unable to have a central venous catheter
  • Patients with hepatic impairment (Patients with elevated bilirubin)
  • Patients with renal impairment (Patients with serum creatinine >1.5 mg/dL)
  • Patients with hematologic impairment (baseline neutrophil counts of less than 1,500 cells/mm3 and platelets count of less than 100,000 cells/mm3)
  • Patients with serious impaired cardiac function (patients with cardiac disease and with reduction of the QRS complex)
  • AIDS-related Kaposi's sarcoma
  • Lactation or pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trabectedin + PLD
Trabectedin + PLD according to SmPC
Drug: Trabectedin + PLD
Combination of Trabectedin + PLD: PLD 30 mg/m2 intravenous (IV) infusion over 90 minutes + trabectedin 1.1 mg/m2 IV infusion over 3 hours every 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Patient will be followed during 37 weeks
ORR will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST V 1.1).
Patient will be followed during 37 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Patient will be followed during 37 weeks
PFS is defined as the time from the 1st treatment cycle until objective tumor progression or death
Patient will be followed during 37 weeks
Safety according to CTCAE v4.0
Time Frame: Patient will be followed during 37 weeks
To assess patient safety and the tolerance of trabectedin + PLD
Patient will be followed during 37 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suriya Yessentayeva

Collaborators

Johnson & Johnson

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 28, 2017

Primary Completion (ANTICIPATED)

March 20, 2019

Study Completion (ANTICIPATED)

May 20, 2019

Study Registration Dates

First Submitted

February 13, 2018

First Submitted That Met QC Criteria

February 23, 2018

First Posted (ACTUAL)

February 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2018

Last Update Submitted That Met QC Criteria

February 23, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R279741OVC4001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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