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

Sponsor
AGO Research GmbH
Study ID
NCT03690739
Phase
PHASE3
Status
Terminated

Conditions

  • Recurrent Ovarian Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Administration according to investigator's discretion
  • Gemcitabine — DRUG
    Administration according to investigator's discretion
  • Bevacizumab — DRUG
    Administration according to investigator's discretion
  • PLD — DRUG
    Administration according to investigator's discretion
  • Paclitaxel — DRUG
    Administration according to investigator's discretion
  • PLD — DRUG
    Administration 30 mg/m² q21
  • Trabectedin — DRUG
    Administration 1.1 mg/m² q21
  • Cisplatin — DRUG
    Administration according to investigator's discretion

Study Details

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.

Key Dates

First listed
Oct 1, 2018
Start date
Aug 9, 2019
Status verified
Feb 2022
Primary completion
Mar 3, 2021
Completion
Mar 3, 2021

Study Design

Enrollment
9 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: platinum-based chemotherapy
    According to the investigator's discretion
  • Active Comparator: PLD + Trabectedin
    PLD 30 mg/m² + Trabectedin 1.1 mg/m² q21

Primary Outcome Measure

Symptom Benefit Rate [ Time Frame: from Baseline to 8 or 9 weeks after randomization, assessed at each visit ]

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