Spots Global Cancer Trial Database for Trabectedin, Doxorubicin and Olaratumab in Patients With Metastatic or Recurrent Leiomyosarcoma
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Trial Identification
Brief Title: Trabectedin, Doxorubicin and Olaratumab in Patients With Metastatic or Recurrent Leiomyosarcoma
Official Title: A Phase I Study of Trabectedin in Combination With Fixed Doses of Doxorubicin and Olaratumab in Patients With Metastatic or Recurrent Leiomyosarcoma
Study ID: NCT03437070
Conditions
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Marilyn Huang, MD, MS
Affiliation: University of Miami
Role: PRINCIPAL_INVESTIGATOR
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