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Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer

NCT03690739 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-02-24

No results posted yet for this study

Summary

This is an open-label, prospective, randomized, controlled, parallel group, multi-center phase III trial to evaluate the Symptom Benefit Rate of trabectedin/PLD in patients with recurrent ovarian cancer who achieve a stabilization of disease after 3 cycles of platinum-based reinduction therapy and with no clinical benefit.

Conditions

  • Recurrent Ovarian Carcinoma

Interventions

DRUG

Carboplatin

Administration according to investigator's discretion

DRUG

Gemcitabine

Administration according to investigator's discretion

DRUG

Bevacizumab

Administration according to investigator's discretion

DRUG

PLD

Administration according to investigator's discretion

DRUG

Paclitaxel

Administration according to investigator's discretion

DRUG

PLD

Administration 30 mg/m² q21

DRUG

Trabectedin

Administration 1.1 mg/m² q21

DRUG

Cisplatin

Administration according to investigator's discretion

Sponsors & Collaborators

  • AGO Research GmbH

    lead INDUSTRY

Principal Investigators

  • Felix Hilpert, MD, PhD · Mammazentrum am Krankenhaus Jerusalem, Hamburg

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-09
Primary Completion
2021-03-03
Completion
2021-03-03

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03690739 on ClinicalTrials.gov