GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma

Part of paid clinical trials in Santa Monica, California.

Sponsor
Sarcoma Oncology Research Center, LLC
Study ID
NCT04535713
Phase
PHASE2
Status
Recruiting
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Conditions

  • Sarcoma

Eligibility Criteria

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

Interventions

  • Gemcitabine — DRUG
    600 mg/m2 (Maximum Dose: 1000 mg) i.v. on Day 1 and Day 8 of Cycle 1+
  • Doxorubicin — DRUG
    18 mg/m2 (Maximum Dose: 32 mg) i.v. on Day 1 and Day 8 of Cycle 1+
  • Docetaxel — DRUG
    25 mg/m2 (Maximum Dose: 42 mg) i.v. on Day 1 and Day 8 of Cycle 1+
  • Nivolumab — DRUG
    240 mg i.v. on Day 1 beginnning Cycle 2+

Study Details

This is an open label phase 2 study for advanced sarcoma using metronomic doses of gemcitabine, doxorubicin and docetaxel, and nivolumab immunotherapy given intravenously.

Key Dates

Start date
Sep 30, 2020
Status verified
Jul 2024
Primary completion
Sep 30, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: Single arm
    A total of 260 patients will receive gemcitabine 600 mg/m2 (maximum dose: 1000 mg) on D1 and D8, doxorubicin 18 mg/m2 on D1 and D8 (maximum dose: 32 mg), docetaxel 25 mg/m2 on D1 and D8 (maximum dose: 42 mg), on Days 1 and 8. After the first cycle, nivolumab 240 mg IV will be added on Day 1 of each cycle (see product information; www.accessdata.fda.gov). Treatment cycles are given every 3 weeks. Patients in this study may continue treatment until significant disease progression or unacceptable toxicity occurs up to one year of therapy. Patients who withdraw or do not complete the first 2 treatment cycles and first follow up CT scan/MRI will be replaced.

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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