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

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. Identifier: NCT03446495
Recruitment Status : Unknown
Verified February 2018 by Suriya Yessentayeva, Scientific Medical Society, Kazakhstan.
Recruitment status was:  Recruiting
First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Johnson & Johnson
Information provided by (Responsible Party):
Suriya Yessentayeva, Scientific Medical Society, Kazakhstan

Brief Summary:
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.

Condition or disease Intervention/treatment
Ovarian Cancer Drug: Trabectedin + PLD

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : March 20, 2019
Estimated Study Completion Date : May 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Trabectedin

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.

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with relapsed ovarian cancer

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03446495

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Contact: Suriya Yessentaeva, PhD +77077942910

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Almaty oncological center Recruiting
Almaty, Kazakhstan
Contact: Rinat Baituganov, PhD    +7 (727) 382 61 60   
Principal Investigator: Rinat Baituganov, PhD         
Almaty regional oncological dispensary Recruiting
Almaty, Kazakhstan
Contact: Sayakhat Olzhaev, PhD    +77273993881   
Principal Investigator: Sayakhat Olzhaev, PhD         
Kazakh institute of oncology and radiology Recruiting
Almaty, Kazakhstan
Contact: Dilara Kaidarova, Academician    + 7 727 292 00 61   
Principal Investigator: Dilara Kaidarova, academician         
Kazakh institute of oncology and radiology Recruiting
Almaty, Kazakhstan
Contact: Oxana Shatkovskaya, PhD    +77014147124   
Principal Investigator: Oxana Shatkovskaya, PhD         
Astana Oncology Center Recruiting
Astana, Kazakhstan
Contact: Mukhtar Tuleutaev, PhD    +77172560073      
Principal Investigator: Mukhtar Tuleutaev, PhD         
Kyzylorda regional Oncological center Recruiting
Kyzylorda, Kazakhstan
Contact: Saken Sergaziyev, PhD    +77242235468   
Principal Investigator: Saken Sergaziyev, PhD         
West Kazakhstan regional oncology dispensary Recruiting
Oral, Kazakhstan
Contact: Esengeldy Rabaev, PhD         
Principal Investigator: Esengeldy Rabaev, PhD         
North Kazakhstan Regional Oncology Center Recruiting
Petropavlovsk, Kazakhstan
Contact: Ermek Abdrimov, PhD    +77152463201   
Principal Investigator: Ermek Abdrimov, PhD         
South Kazakhstan regional oncologic dispensary Recruiting
Shymkent, Kazakhstan
Contact: Dauranbek Arybzhanov, PhD    +77252221904   
Principal Investigator: Dauranbek Arybzhanov, ЗрВ         
East Kazakhstan Regional Oncology Dispensary Recruiting
Ust-Kamenogorsk, Kazakhstan
Contact: Gulmira Sagidullina, PhD    +77112705976   
Principal Investigator: Gulmira Sagidullina, PhD         
Sponsors and Collaborators
Suriya Yessentayeva
Johnson & Johnson
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Responsible Party: Suriya Yessentayeva, Chair, Scientific Medical Society, Kazakhstan Identifier: NCT03446495    
Other Study ID Numbers: R279741OVC4001
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suriya Yessentayeva, Scientific Medical Society, Kazakhstan:
ovarian cancer, trabectedin, recurrent ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents