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Trabectedin/Caelyx vs Cisplatin Hypersensitivity in Relapsed Ovarian Cancer Patients Allergic to Platinum

NCT05512676 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2022-08-23

No results posted yet for this study

Summary

Observational, clinical study. Intention to include 40 patients (20 patients treated with trabectedin and 20 with cisplatin hypersensitivity) The investigators investigate the role of trabectedin in combination with PLD and cisplatin in treating platinum sensitive ROC being allergic to carboplatin. The investigators focus on adverse events and evaluate if these are tolerable for the patients and further evaluate the measurable treatment effect on the tumor burden.

Conditions

  • Ovarian Neoplasm
  • Chemotherapeutic Toxicity
  • Chemotherapy Effect
  • Chemotherapy-induced Neutropenia
  • Chemotherapy-induced Nausea and Vomiting

Sponsors & Collaborators

  • Swedish Orphan Biovitrum

    collaborator INDUSTRY

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Erik Rokkones, PhD · Head of Gyn. Onc. Department, Oslo University Hospital

  • Torbjørn Paulsen, PhD · Oslo University hospital, Dept. Gyn. Oncology, Norway

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-07
Primary Completion
2019-05-20
Completion
2022-08-01

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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 NCT05512676 on ClinicalTrials.gov