Targeting ATR in Soft-tissue Sarcomas: a Randomized Phase II Study. TARSARC Study
Multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trial to assess the antitumor activity of berzosertib in association with gemcitabine
• 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,
• Patients must have measurable disease defined as per RECIST v1.1
⁃ Patient must comply with the collection of tumor biopsies, and tumors must be accessible for biopsy,
⁃ At least three weeks since last chemotherapy, immunotherapy or any other pharmacological treatment and/or radiotherapy,
⁃ Adequate hematological, renal, metabolic and hepatic function
⁃ Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization.
⁃ Both women of childbearing potential and men must agree to use a highly effective method of contraception 28 days before start of first dose of study drug
⁃ No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,
⁃ Recovery to grade ≤ 1 from any adverse event (AE) derived from previous treatment
⁃ Voluntarily signed and dated written informed consent prior to any study specific procedure,
⁃ Patients with a social security in compliance with the French law.