Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
PharmaMar
Study ID
NCT06088290
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Leiomyosarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lurbinectedin — DRUG
    IV Infusion
  • Doxorubicin — DRUG
    Short IV push or bolus (according to label)

Study Details

The primary objective of this phase III study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent.

Key Dates

Start date
Sep 21, 2023
Status verified
May 2026
Primary completion
Aug 30, 2029
Completion
Aug 30, 2029

Study Design

Enrollment
455 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Doxorubicin (Dose A) + Lurbinectedin (Dose B)
    Participants will receive doxorubicin and lurbinectedin intravenously (IV) every three weeks (q3wk) on Day 1 of each treatment cycle (treatment cycle = three weeks).
  • Experimental: Doxorubicin (Dose C) + Lurbinectedin (Dose D)
    Participants will receive doxorubicin IV q3wk on Day 1 of each treatment cycle (treatment cycle = three weeks).
  • Active Comparator: Doxorubicin
    Participants will receive doxorubicin IV q3wk on Day 1 of each treatment cycle (treatment cycle = three weeks).

Primary Outcome Measure

PFS by IRC [ Time Frame: Up to approximately 41 months ]

Locations (24)

FacilityCityStateZIPSite coordinators
Mayo Clinic Hospital - PhoenixPhoenixArizona85054-
Precision NextGen Oncology & Research CenterBeverly HillsCalifornia90212-
Cedars-Sinai Medical CenterLos AngelesCalifornia90025-
Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Sarcoma Oncology CenterLos AngelesCalifornia90057-
Stanford University (Leland Stanford Junior University)Palo AltoCalifornia94304-
University of Colorado Hospital - Anschutz Medical CampusAuroraColorado80045-
Mayo Clinic - JacksonvilleJacksonvilleFlorida32224-
Moffitt Cancer CenterTampaFlorida33612-
Augusta University Georgia Cancer CenterAugustaGeorgia30912-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-
Mayo Clinic - RochesterRochesterMinnesota55905-
Washington University School of Medicine in St. LouisSt LouisMissouri63110-
Memorial Sloan Kettering Cancer Center - New YorkNew YorkNew York10065-
Cleveland Clinic Main CampusClevelandOhio44195-
Oregon Health and Science UniversityPortlandOregon97239-
University of Pennsylvania Abramson Cancer CenterPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical Center (UPMC) Hillman Cancer CenterPittsburghPennsylvania15232-
Vanderbilt - Ingram Cancer CenterNashvilleTennessee37232-
UT Southwestern Harold C. Simmons Comprehensive Cancer CenterDallasTexas75390-8562-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Fred Hutchinson Cancer Center - Seattle Cancer Care Alliance (SCCA) LocationSeattleWashington98109-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Hospital - Phoenix· Phoenix, AZPrecision NextGen Oncology & Research Center· Beverly Hills, CACedars-Sinai Medical Center· Los Angeles, CANorris Comprehensive Cancer Center· Los Angeles, CASarcoma Oncology Center· Los Angeles, CAStanford University (Leland Stanford Junior University)· Palo Alto, CA

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