NCT04807816

Targeting ATR in Soft-tissue Sarcomas

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a multicenter, prospective, open-labeled, 2-arm, non-comparative randomized (2:1) phase II trial. Patients will be randomized between arm A (gemcitabine + berzosertib) and arm B (gemcitabine) with two patients randomized in arm A for one patient randomized in arm B.

Conditions

• Leiomyosarcoma, Adult

Interventions

Type	Name	Description
DRUG	Association 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.
DRUG	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. A treatment cycle consists of 3 weeks (i.e., 21 days) and will be administered during hospitalization.

Timeline

• Start date: 2022-02-09
• Primary completion: 2026-06-01
• Completion: 2027-12-01
• First posted: 2021-03-19
• Last updated: 2025-10-02

Locations

6 sites across 1 country: France