NCT03690739

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

Trabectedin/PLD Versus Continuation of Platinum-based Chemo-therapy in Patients With Disease Stabilization and no Symptom Benefit Under Platinum-based Chemotherapy for Recurrent Ovarian Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: AGO Research GmbH · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 330 patients will be randomized in a 1:1 ration to the treatments specified below: Arm A - Platinum-based chemotherapy according to investigator's discretion Arm B - Pegylated liposomal doxorubicin 30 mg/m² + Trabectedin 1.1 mg/m² (q3w)

Conditions

• Recurrent Ovarian Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-08-09
• Primary completion: 2021-03-03
• Completion: 2021-03-03
• First posted: 2018-10-01
• Last updated: 2022-02-24

Locations

29 sites across 1 country: Germany