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

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ClinicalTrials.gov Identifier: NCT02825420
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
PharmaMar

Brief Summary:
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

Condition or disease Intervention/treatment
Relapsed Ovarian Cancer Drug: trabectedin

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Study Type : Observational
Actual Enrollment : 224 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: NonInterventional, 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
Study Start Date : June 2015
Actual Primary Completion Date : August 2019
Actual Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Trabectedin




Primary Outcome Measures :
  1. PFS after trabectedin + PLD therapy [ Time Frame: 18 months ]
    PFS after trabectedin + PLD therapy for the treatment of relapsed ovarian cancer according to SmPC, while describing patients who were pretreated with an antiangiogenic drug and those not pretreated in real-life clinical practice



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with platinum-sensitive relapsed ovarian cancer who are receiving trabectedin + PLD according to SmPC.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825420


Locations
Show Show 65 study locations
Sponsors and Collaborators
PharmaMar
Investigators
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Study Chair: María José Pontes PharmaMar
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Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT02825420    
Other Study ID Numbers: ET-D-031-14
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Trabectedin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents