Trials / Completed
CompletedNCT02398058
Trabectedin Plus Olaparib in Metastatic or Advanced Sarcomas (TOMAS)
A Phase Ib Study on the Combination of Trabectedin and Olaparib in Unresectable Advanced/Metastatic Sarcomas After Failure of Standard Therapies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Italian Sarcoma Group · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1b, multi-site, open-label, non-randomized clinical trial evaluating the safety, tolerability, and pharmacokinetics of escalating doses of olaparib and trabectedin in patients with unresectable advanced/metastatic sarcomas. Patients will continue to be treated on this combination regimen in the absence of disease progression, intolerable toxicity or patient's decision.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | trabectedin | trabectedin will be administered in a 24-h continuous i.v. infusion every 3 weeks |
| DRUG | olaparib | olaparib will be administered in a continuous daily dose every 12 hours |
Timeline
- Start date
- 2014-07-20
- Primary completion
- 2019-12-01
- Completion
- 2019-12-01
- First posted
- 2015-03-25
- Last updated
- 2021-04-14
Locations
3 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT02398058. Inclusion in this directory is not an endorsement.