Clinical Trials Logo
  1. Home
  2. Leiomyosarcoma
  3. NCT03437070

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Status Withdrawn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
See also
  Status Clinical Trial Phase
Recruiting NCT04535271 - Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Leiomyosarcoma Phase 2
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT06088290 - Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma Phase 2/Phase 3
Withdrawn NCT04906876 - A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas Phase 2
Terminated NCT02940041 - Concordance Between Sonography Amd MRI for Presurgical Diagnosis of Uterine Mesenchymal Malignant Tumors
Completed NCT01442662 - Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patient With Metastatic or Relapsed Uterine Phase 2
Completed NCT00062868 - LMP-specific T-cells for Patients With Relapsed EBV-positive Lymphoma Phase 1
Recruiting NCT04214457 - Development of a Predictive Model for Early Differential Diagnosis of Uterine Leiomyomas and Leiomyosarcomas
Active, not recruiting NCT04420975 - Nivolumab and BO-112 Before Surgery for the Treatment of Resectable Soft Tissue Sarcoma Phase 1
Terminated NCT04099277 - A Study of LY3435151 in Participants With Solid Tumors Phase 1
Not yet recruiting NCT05548179 - Exploring Clinical Trial Experiences of People With Leiomyosarcoma
Recruiting NCT02983539 - Detection of Circulating Tumor Cells in Patients With Sarcomas
Completed NCT00093080 - Study of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED) Phase 2
Active, not recruiting NCT04624178 - A Study of Rucaparib and Nivolumab in People With Leiomyosarcoma Phase 2
Terminated NCT03959033 - Patient Reported Outcome Measures (PROMs) With Trabectedin
Recruiting NCT02275286 - Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients Phase 1/Phase 2
Active, not recruiting NCT01956084 - Cytotoxic T Cells to Treat Relapsed EBV-positive Lymphoma Phase 1
Completed NCT01426633 - Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas Phase 1
Completed NCT00400569 - Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma Phase 2
Recruiting NCT05080790 - Treatment With Dinutuximab Beta, Zoledronic Acid and Low-dose Interleukin (IL-2) in Patients With Leiomyosarcoma Phase 2