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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03446495 |
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Date of registration:
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13/02/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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 |
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Scientific title:
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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 |
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Date of first enrolment:
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March 28, 2017 |
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Target sample size:
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60 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03446495 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Kazakhstan
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Contacts
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Name:
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Suriya Yessentaeva, PhD |
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Address:
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Telephone:
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+77077942910 |
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Email:
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surya_esentay@mail.ru |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ovarian Cancer
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Intervention(s)
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Drug: Trabectedin + PLD
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Primary Outcome(s)
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Objective Response Rate (ORR)
[Time Frame: Patient will be followed during 37 weeks]
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Secondary Outcome(s)
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Progression-Free Survival (PFS)
[Time Frame: Patient will be followed during 37 weeks]
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Safety according to CTCAE v4.0
[Time Frame: Patient will be followed during 37 weeks]
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Secondary ID(s)
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R279741OVC4001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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