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Trabectedin, Doxorubicin and Olaratumab in Patients With Metastatic or Recurrent Leiomyosarcoma

Leiomyosarcoma Clinical Trial

Official title:
A Phase I Study of Trabectedin in Combination With Fixed Doses of Doxorubicin and Olaratumab in Patients With Metastatic or Recurrent Leiomyosarcoma

Clinical Trial Summary

This study seeks to determine if addition of trabectedin (T) to combination doxorubicin (D) and olaratumab (O), is feasible and tolerable with antitumor activity in metastatic or recurrent Leiomyosarcomas (LMS) patients who have limited therapeutic options.

Clinical Trial Description

This is a traditional 3+3 phase I trial design to identify the recommended phase II dose (RP2D) of Trabectedin [T] that can be used in combination with Doxorubicin [D] and Olaratumab [O] for the treatment of patients with advanced stage or recurrent LMS.

Patients will be treated at an assigned dose level of combination therapy per dose escalation design. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03437070
Study type Interventional
Source University of Miami
Contact
Status Withdrawn
Phase Phase 1
Start date June 2019
Completion date June 2023
View Details
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