Lurbinectedin + Doxorubicin In Leiomyosarcoma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Massachusetts General Hospital
Study ID
NCT05099666
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Leiomyosarcoma
  • Advanced Soft-tissue Sarcoma
  • Leiomyosarcoma Metastatic
  • Metastatic Soft-tissue Sarcoma

Eligibility Criteria

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

Interventions

  • Lurbinectedin — DRUG
    Dosage per protocol, escalation per protocol, IV over 60 minutes (± 5 minute infusion window), schedule per protocol
  • Doxorubicin — DRUG
    Dosage per protocol, IV per institutional standards of practice and the FDA package insert, schedule per protocol

Study Details

This research study involves the study drug lurbinectedin in combination with doxorubicin. This research has two parts. The first part is being done to determine the tolerability of lurbinectedin with doxorubicin in people with soft tissue sarcoma. The second part is a randomized study to determine which is more effective at treating leiomyosarcoma, lurbinectedin with doxorubicin or lurbinectedin alone.

Key Dates

Start date
Feb 4, 2022
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lurbinectedin + Doxorubicin Phase I
    The phase 1b trial will follow a standard 3+3 design. Upon determination of the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of lurbinectedin plus doxorubicin. A treatment cycle will be defined as 21 consecutive days. Treatment will be administered on an outpatient basis * Lurbinectedin * Doxorubicin
  • Experimental: Lurbinectedin + Doxorubicin at RP2D
    The randomized two arm phase 2 trial will begin following the determination of the RP2D for lurbinectedin and doxorubicin. * Participants will be randomized 1:1 to enroll to either Arm 1 or Arm 2 * Participants enrolled to Arm 1 will receive Lurbinectedin with Doxorubicin at the RP2D defined during the phase 1b portion of the trial.
  • Active Comparator: Doxorubicin Monotherapy
    The randomized two arm phase 2 trial will begin following the determination of the RP2D for lurbinectedin and doxorubicin. * Participants will be randomized 1:1 to enroll to either Arm 1 or Arm 2 * Participants enrolled to Arm 2 will receive Doxorubicin at the standard dose of 75 mg/m2

Primary Outcome Measure

The maximum tolerated dose (MTD) of lurbinectedin with doxorubicin in participants with advanced soft-tissue sarcoma [ Time Frame: 21 Days ]

Locations (6)

FacilityCityStateZIPSite coordinators
Mayo ArizonaPhoenixArizona85054-
Mayo JacksonvilleJacksonvilleFlorida32224-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02115-
Mayo RochesterRochesterMinnesota55905-
Memorial Sloan KetteringNew YorkNew York10065-

Find similar trials in Phoenix, AZ

By research site
Mayo Arizona· Phoenix, AZMayo Jacksonville· Jacksonville, FLDana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAMayo Rochester· Rochester, MNMemorial Sloan Kettering· New York, NY

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