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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03446495
Other study ID # R279741OVC4001
Secondary ID
Status Recruiting
Phase N/A
First received February 13, 2018
Last updated February 23, 2018
Start date March 28, 2017
Est. completion date May 20, 2019

Study information

Verified date February 2018
Source Scientific Medical Society, Kazakhstan
Contact Suriya Yessentaeva, PhD
Phone +77077942910
Email surya_esentay@mail.ru
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date May 20, 2019
Est. primary completion date March 20, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Kazakhstan Almaty oncological center Almaty
Kazakhstan Almaty regional oncological dispensary Almaty
Kazakhstan Kazakh institute of oncology and radiology Almaty
Kazakhstan Kazakh institute of oncology and radiology Almaty
Kazakhstan Astana Oncology Center Astana
Kazakhstan Kyzylorda regional Oncological center Kyzylorda
Kazakhstan West Kazakhstan regional oncology dispensary Oral
Kazakhstan North Kazakhstan Regional Oncology Center Petropavlovsk
Kazakhstan South Kazakhstan regional oncologic dispensary Shymkent
Kazakhstan East Kazakhstan Regional Oncology Dispensary Ust-Kamenogorsk

Sponsors (2)

Lead Sponsor Collaborator
Suriya Yessentayeva Johnson & Johnson

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) ORR will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST V 1.1). Patient will be followed during 37 weeks
Secondary Progression-Free Survival (PFS) PFS is defined as the time from the 1st treatment cycle until objective tumor progression or death Patient will be followed during 37 weeks
Secondary Safety according to CTCAE v4.0 To assess patient safety and the tolerance of trabectedin + PLD Patient will be followed during 37 weeks
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