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Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients (NIMES-ROC)

P

Pharma Mar

Status

Completed

Conditions

Relapsed Ovarian Cancer

Treatments

Drug: trabectedin

Study type

Observational

Funder types

Industry

Identifiers

NCT02825420
ET-D-031-14

Details and patient eligibility

About

Non-interventional, multicenter, prospective, European study to describe the effectiveness of trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to SmPC regardless of previous use of an antiangiogenic drug

Enrollment

220 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women aged 18 years or older.
  • Presence of platinum-sensitive relapsed ovarian cancer.
  • Treatment and treated indication according to local label SmPC and reimbursement for trabectedin and PLD treatment.
  • Prior treatment with a minimum of 1 cycle of trabectedin + PLD according to SmPC before inclusion in the study, and no more than 3 previous treatment lines.
  • Written informed consent indicating that patients understand the purpose and procedures and are willing to participate in the study.

Exclusion criteria

  • None

Trial design

Trial documents
2

Trial contacts and locations

65

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Data sourced from clinicaltrials.gov

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