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

Who is this study for? Adults with Leiomyosarcoma
What treatments are being studied? Gemcitabine
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Institut Bergonié
RECRUITING
Bordeaux
Centre Leon Berard
RECRUITING
Lyon
CHU Poitiers
RECRUITING
Poitiers
Institut de Cancérologie de l'Ouest
WITHDRAWN
Saint-herblain
IUCT Oncopôle
RECRUITING
Toulouse
Institut Gustave Roussy
RECRUITING
Villejuif
Contact Information
Primary
Antoine ITALIANO, MD, PhD
a.italiano@bordeaux.unicancer.fr
(0)5.56.33.33.33
Backup
Simone MATHOULIN-PELISSIER, MD, PhD
s.mathoulin@bordeaux.unicancer.fr
Time Frame
Start Date: 2022-02-09
Estimated Completion Date: 2027-12
Participants
Target number of participants: 72
Treatments
Experimental: Experimental Arm A: treatment by berzosertib combined with gemcitabine
Patients with advanced leiomyosarcomas will be treated with berzosertib combined with gemcitabine
Other: Standard Arm B: treatment by gemcitabine alone
Patients with advanced leiomyosarcomas will be treated with with gemcitabine alone (control arm)
Related Therapeutic Areas
Sponsors
Collaborators: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Leads: Institut Bergonié

This content was sourced from clinicaltrials.gov

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