NCT03437070

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Leiomyosarcoma

Interventions

Type	Name	Description
DRUG	Trabectedin	Administered intravenously per protocol on Day 1 for 21-day cycles.
DRUG	Doxorubicin	Administered intravenously per protocol on Day 1 for 21-day cycles.
DRUG	Olaratumab	Administered intravenously per protocol

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-06-01
• Completion: 2023-06-01
• First posted: 2018-02-19
• Last updated: 2019-03-18

Regulatory

• FDA-regulated drug study