NCT03446495

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
unknown

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

Study Start

First participant enrolled

March 28, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2019

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

February 13, 2018

Last Update Submit

February 23, 2018

Conditions

Ovarian Cancer

Keywords

ovarian cancer, trabectedin, recurrent ovarian cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Progression-Free Survival (PFS)

    Patient will be followed during 37 weeks

  • Safety according to CTCAE v4.0

    Patient will be followed during 37 weeks

Study Arms (1)

Trabectedin + PLD

Trabectedin + PLD according to SmPC

Drug: Trabectedin + PLD

Interventions

Trabectedin + PLDDRUG

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.

Trabectedin + PLD

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with relapsed ovarian cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Almaty oncological center

Almaty, Kazakhstan

RECRUITING

Almaty regional oncological dispensary

Almaty, Kazakhstan

RECRUITING

Kazakh institute of oncology and radiology

Almaty, Kazakhstan

RECRUITING

Kazakh institute of oncology and radiology

Almaty, Kazakhstan

RECRUITING

Astana Oncology Center

Astana, Kazakhstan

RECRUITING

Kyzylorda regional Oncological center

Kyzylorda, Kazakhstan

RECRUITING

West Kazakhstan regional oncology dispensary

Oral, Kazakhstan

RECRUITING

North Kazakhstan Regional Oncology Center

Petropavl, Kazakhstan

RECRUITING

South Kazakhstan regional oncologic dispensary

Shymkent, Kazakhstan

RECRUITING

East Kazakhstan Regional Oncology Dispensary

Ust-Kamenogorsk, Kazakhstan

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Trabectedin1-dodecylpyridoxal

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

DioxolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Suriya Yessentaeva, PhD

CONTACT

+77077942910surya_esentay@mail.ru

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chair

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 26, 2018

Study Start

March 28, 2017

Primary Completion

March 20, 2019

Study Completion

May 20, 2019

Last Updated

February 26, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

KA(10)