RecruitingPhase 2NCT04807816

Targeting ATR in Soft-tissue Sarcomas

Targeting ATR in Soft-tissue Sarcomas: a Randomized Phase II Study. TARSARC Study


Sponsor

Institut Bergonié

Enrollment

72 participants

Start Date

Feb 9, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trial to assess the antitumor activity of berzosertib in association with gemcitabine


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug that targets a cellular stress response pathway (ATR inhibitor) in people with leiomyosarcoma — a rare soft-tissue cancer — that has spread or cannot be surgically removed and has continued to grow despite prior treatment. **You may be eligible if...** - You have been diagnosed with leiomyosarcoma (confirmed by biopsy) - Your cancer has spread or is locally advanced and cannot be removed by surgery - Your cancer has continued to grow during previous treatment - You are 18 or older, in reasonably good health (ECOG ≤ 1) - You have received no more than 3 prior lines of treatment for advanced disease - Your expected survival is more than 3 months **You may NOT be eligible if...** - You have had more than 3 prior lines of treatment - You are a candidate for surgery with curative intent - You have severe organ damage Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAssociation of berzosertib with gemcitabine

Gemcitabine will be administered by intravenous 30-minutes infusion on days 1 and 8 every 3 weeks, at a fixed dose of 1000 mg/m². Berzosertib will be administered intravenously on days 2 and 9 every 3 weeks (210 mg/m²). A treatment cycle consists of 3 weeks (i.e., 21 days) and will be administered during hospitalization.

DRUGGemcitabine

Gemcitabine will be administered by intravenous 30-minutes infusion on days 1 and 8 every 3 weeks, at a fixed dose of 1000 mg/m². A treatment cycle consists of 3 weeks (i.e., 21 days) and will be administered during hospitalization.


Locations(6)

Institut Bergonié

Bordeaux, France

Centre Leon Berard

Lyon, France

CHU Poitiers

Poitiers, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

IUCT Oncopôle

Toulouse, France

Institut Gustave Roussy

Villejuif, France

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NCT04807816