CompletedPhase 2

Targeting ATR in Soft-tissue Sarcomas

France58 participantsStarted 2022-02-09

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologically confirmed leiomyosarcomas.
✓. Metastatic or unresectable locally advanced disease,
✓. Documented progression according to RECIST v1.1 confirmed by central review,
✓. Age ≥ 18 years,
✓. ECOG ≤ 1,
✓. Life expectancy \> 3 months,
✓. No more than 3 previous line of systemic therapy for advanced disease,
✓. Patients must have advanced disease and must not be a candidate for other approved therapeutic regimen known to provide significant clinical benefit based on investigator judgement,

Exclusion criteria

✕. Previous treatment with Gemcitabine, or berzosertib or other ATR inhibitor,
✕. Evidence of progressive or symptomatic central nervous system or leptomeningeal metastases,
✕. Women who are pregnant or breast feeding,
✕. Participation to a study involving a medical or therapeutic intervention in the last 30 days,
✕. Previous enrolment in the present study,
✕. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,
✕. Known hypersensitivity to any involved study drug or any of its formulation components,
✕. Has known active hepatitis B or hepatitis C,

What they're measuring

Assessment of the antitumor activity of berzosertib combined with gemcitabine

Timeframe: 6 months

Assessment of the antitumor activity of gemcitabine

Timeframe: 6 months

Trial details

NCT IDNCT04807816

SponsorInstitut Bergonié

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-29

View on ClinicalTrials.gov More Leiomyosarcoma, Adult trials