Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma

Part of paid clinical trials in Santa Monica, California.

Sponsor
Sarcoma Oncology Research Center, LLC
Study ID
NCT04535271
Phase
PHASE2
Status
Recruiting
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Conditions

  • Leiomyosarcoma

Eligibility Criteria

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

Interventions

  • Trabectedin — DRUG
    This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.

Study Details

This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.

Key Dates

Start date
Sep 9, 2021
Status verified
Feb 2025
Primary completion
Sep 30, 2028
Completion
Mar 30, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm
    Trabectedin 24 h CIV 0.5 mg/m2 D1 and D8 Gemcitabine i.v. 250 mg/m2 D1 and D8 Dacarbazine i.v. 250 mg/m2 D1 and D8

Primary Outcome Measure

Progression free survival [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sant P ChawlaSanta MonicaCalifornia90403
Sant P Chawla, MD
[email protected]
310-552-9999
Victoria Chua-Alcala, MD
[email protected]
3105529999

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Sant P Chawla· Santa Monica, CA

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