Trials / Completed
CompletedNCT02993705
Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)
Phase II Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
- Sex
- Female
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
Multicenter phase II study on trabectedin in patients advanced uterine and ovarian carcinosarcoma. Patients will receive trabectedin until disease progression or unacceptable toxicity. Disease response evaluation will be assessed every 9 weeks.
Detailed description
This is a Phase II, multi-centre, single arm study aiming at evaluating efficacy and toxicity of Trabectedin in a population of advanced or recurrent ovarian and uterine carcinosarcoma. Trabectedin will be infused at the dose of 1.3 mg/m2 as a 3- hour iv infusion every 3 weeks via a central venous catheter.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Trabectedin | Chemotherapy drug |
Timeline
- Start date
- 2017-02-22
- Primary completion
- 2019-11-13
- Completion
- 2019-11-13
- First posted
- 2016-12-15
- Last updated
- 2021-08-25
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT02993705. Inclusion in this directory is not an endorsement.