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Leiomyosarcoma clinical trials

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NCT ID: NCT03810976 Completed - Sarcoma Clinical Trials

A Study of Eribulin With Gemcitabine in Patients With Advanced Liposarcoma or Leiomyosarcoma

Start date: March 27, 2018
Phase: Phase 2
Study type: Interventional

The eribulin, a microtubule-dynamics inhibitor was approved for specific subtypes of STS. Eribulin demonstrated significantly better OS compared to dacarbazine in previously treated patients with liposarcoma and leiomyosarcoma and approved as standard treatment. However, the median progression free survival (PFS) and response rate (RR) was similar for both groups which remains modest outcome of 2.6 months of PFS and 4% of RR. Therefore, to improve antitumor activity, further combination strategy is strongly warranted. Based on the previous studies, investigators suggest phase II trial of eribulin and gemcitabine combination in previously treated patients with unresectable, advanced, or metastatic leiomyosarcoma or liposarcoma.

NCT ID: NCT03761095 Completed - Leiomyosarcoma Clinical Trials

A Study of Unesbulin (PTC596) in Combination With Dacarbazine in Participants With Advanced Leiomyosarcoma (LMS)

Start date: March 13, 2019
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of unesbulin in combination with dacarbazine for the treatment of advanced LMS and determine the overall safety profile of unesbulin in combination with dacarbazine. This study will employ the time-to-event continual reassessment method (TITE-CRM) for dose finding. Treatment will be initiated at dose level 2 (DL2) (Dacarbazine 1000 milligrams per square meter [mg/m^2] intravenously [IV] every 21 days in combination with unesbulin 200 milligrams [mg] orally twice weekly) for the first participant. This dose level represents the investigator's best assessment of the MTD based on available toxicity data for both agents. For subsequent participants, the dose level at which treatment is initiated will be selected based on the TITE-CRM using the most up to date dose-limiting toxicity (DLT) information from all participants previously treated. To enroll additional participants at the RP2D, the study is amended to include an expansion cohort of up to 12 participants (some of whom could be ongoing participants who reconsent). Treatment will continue for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.

NCT ID: NCT03718091 Completed - Solid Tumor Clinical Trials

M6620 (VX-970) in Selected Solid Tumors

Start date: January 8, 2019
Phase: Phase 2
Study type: Interventional

This research study is studying a drug called M6620 as a possible treatment for advanced solid tumor.

NCT ID: NCT03009201 Completed - Clinical trials for Metastatic Soft Tissue Sarcoma

Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery

Start date: March 10, 2017
Phase: Phase 1
Study type: Interventional

This phase Ib trial studies the side effects and best dose of ribociclib when giving together with doxorubicin hydrochloride in treating patients with soft tissue sarcomas that has spread to other places or that cannot be removed by surgery (advanced). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib and doxorubicin hydrochloride may work better in treating patients with soft tissue sarcoma.

NCT ID: NCT02997358 Completed - Clinical trials for Uterine or Soft Tissue Leiomyosarcoma

Study Comparing Efficacy of Doxorubicin With Trabectedin Followed by Trabectedin Versus Doxorubicine in Patients With Leiomyosarcoma

LMS04
Start date: January 18, 2017
Phase: Phase 3
Study type: Interventional

The objective of LMS04 study is to better define the treatment strategy for patients with metastatic leiomyosarcoma (uterine or soft tissue), as well as identifying the best first line therapeutic option for these patients. LMS04 will test a new strategy for first line therapy LMS sarcoma compare to the reference therapy (6 cycles of doxorubicin alone): the interest of the association of trabectedin to doxorubicin in first line treatment followed by trabectedin alone for non-progressive patients after 6 cycles of the association of trabectedin and doxorubicin (the LMS02 design). LMS04 will be the first phase III randomized study specifically dedicated to soft tissue leiomyosarcoma in first line metastatic disease. It is planned to compare a new doxorubicin combination (including trabectedin) with very encouraging results followed by trabectedin maintenance therapy for non-progressive patients to doxorubicin alone. Prospective ancillary translational studies will attempt to define profiles of patients who could benefit from this new chemotherapy in an exploratory way. The validation of a new first line option specific for LMS, identifying clinical factors that characterize aggressiveness and responsiveness to treatment aims to have an important in the spirit of personalized medicine in this rare and deadly disease.

NCT ID: NCT02584309 Completed - Soft Tissue Sarcoma Clinical Trials

Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma

Start date: February 22, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to look at whether giving a drug called dexrazoxane with standard of care doxorubicin affects the progression of the disease. Dexrazoxane is often given at the same time as doxorubicin to help reduce the incidence and severity of disease of the heart muscle (which can be caused by doxorubicin). In January 2019 Eli Lilly and Company reported that the results of the Phase 3 study of olaratumab (Lartruvo), in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma, did not confirm the clinical benefit of olaratumab in combination with doxorubicin as compared to doxorubicin alone. Therefore olaratumab is being removed from the front line standard of care regimen. Amendment #9 was made to the protocol to reflect these changes to the standard of care treatment.

NCT ID: NCT02303262 Completed - Clinical trials for Metastatic Leiomyosarcoma

SARC018: A Study of Mocetinostat and Gemcitabine in Patients With Metastatic Leiomyosarcoma

Start date: November 12, 2015
Phase: Phase 2
Study type: Interventional

This is an open-label, multi-center, Phase II trial studying the combination of mocetinostat and gemcitabine in patients who have previously demonstrated disease progression either while, or within six months after, receiving chemotherapy with a gemcitabine-based regimen.

NCT ID: NCT02249702 Completed - Leiomyosarcoma Clinical Trials

Activity of Trabectedin or Gemcitabine + Docetaxel in Uterine Leiomyosarcoma

TAUL
Start date: April 2010
Phase: Phase 2
Study type: Interventional

The management of patients with uterine leiomyosarcomas poses many difficulties. Despite 60% of women present with disease limited to the uterus, cure rates range from 20 to 60%. Patients with metastatic disease at diagnosis or who recur after initial treatment have a dismal prognosis and, except for a subset of selected patients with completely resectable disease, the median survival is less than one year. Treatment options for recurrent/metastatic uterine leiomyosarcoma are limited. The most active drugs are doxorubicin ± ifosfamide and gemcitabine + docetaxel (GD) with response rate of 25-55% and 27-53%, respectively. Both these regimens have been increasingly used in the last years also in the adjuvant setting. For relapsed patients other drugs have been tested as single agent but negligible activity was observed. Trabectedin (Yondelis® -T) is a marine-derived cytotoxic approved by EMEA. It is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide or who are unsuitable to receive these agents. Among STS, activity has been mainly detected in synovial sarcoma, liposarcoma and leiomyosarcoma. Although the response rate did not exceed 10%, T was demonstrated to provide disease control, with progression arrest rates exceeding 50% and progression-free survival rates exceeding 20% at 6 months. So far no phase II studies tested the activity of T in uterine leiomyosarcoma specifically. This study is aimed at evaluating the activity of T (arm A) in advanced uterine leiomyosarcomas, having GD (arm B) as an internal control In parallel translational studies will be performed to identify factors predictive of the activity of T in this specific histotype.

NCT ID: NCT02247544 Completed - Leiomyosarcoma Clinical Trials

Efficacy Study on Trabectedin in Retroperitoneal Leiomyosarcoma and Well Differentiated/Dedifferentiated Liposarcoma

TRAVELL
Start date: March 2014
Phase: Phase 2
Study type: Interventional

This is an Italian, multicentre, single arm, phase II study, with an intra-patient comparison end point. This study aims at confirming the activity of the drug trabectedin as second/further line treatment in retroperitoneal leiomyosarcoma and well differentiated/dedifferentiated liposarcoma expressed in terms of slowing down tumour growth. Another objective is to investigate this peculiar benefit of trabectedin in typical retroperitoneal sarcomas may be exploited to help multidisciplinary clinical decision-making in the management of retroperitoneal sarcomas

NCT ID: NCT02131480 Completed - Clinical trials for Uterus Leiomyosarcoma

Study of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma

LMS02
Start date: June 2010
Phase: Phase 2
Study type: Interventional

Uterine leiomyosarcomas and soft tissues are rare tumors with a poor prognosis when metastatic or locally advanced. They have an average chemosensitivity mainly to doxorubicin, ifosfamide, cisplatin, gemcitabine and trabectedin but response rates in combination in first line does not exceed 55% for uterine leiomyosarcomas and 35% for leiomyosarcomas of soft tissue. The trabectedin is a new cancer drug that has obtained marketing authorization after failure of anthracyclines and ifosfamide in the treatment of soft tissue sarcomas (STM) in Europe. It has especially shown efficacy in myxoid liposarcomas, leiomyosarcomas and synoviosarcoma. This study aims to evaluate the usefulness of the combination of trabectedin with doxorubicin in first-line treatment of uterine or soft tissue leiomyosarcoma.