Leiomyosarcoma, AdultPhase 2TARSARCNCT04807816
Targeting ATR in Soft-tissue Sarcomas
A Phase 2 study testing Association of berzosertib with gemcitabine and Gemcitabine in people with Leiomyosarcoma, Adult, run by Institut Bergonié at 5 sites in France.
Trial summary
Multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trial to assess the antitumor activity of berzosertib in association with gemcitabine Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leiomyosarcoma, Adult
- What is being tested?
- Association of berzosertib with gemcitabine and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 5 sitesFrance
- Study dates
- 9 Feb 2022to 21 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- Known hypersensitivity to any involved study drug or any of its formulation components,
- Has known active hepatitis B or hepatitis C,
- Has a known history of Human Immunodeficiency Virus or known acquired immunodeficiency syndrome
- Any of the following cardiac or cardiovascular criteria :
- Congestive heart failure ≥ New York Heart Association (NHYA) class 1,
- Unstable angina , new-onset angina
- Myocardial infarction less than 6 months before start of study drug
- Uncontrolled cardiac arrhythmias,
- Participants with Li Fraumeni syndrome and/or ataxia telangiectasia,
- Active autoimmune disease:
- Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible,
- Patients requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at dose ≤ 10 mg or 10 mg equivalent prednisone day,
- Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intra-ocular or inhalation) are acceptable.
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident , deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication,
- Patients with oral anticoagulation based on Vitamine K antagonist,
- Treatment by potent inhibitors or inducers of CYP3A4
- Vaccination with yellow fever or by any other live attenuated vaccine in the last 30 days,
- Individuals deprived of liberty or placed under legual guardianship.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Institut Bergonié
Bordeaux, 33076
Centre Leon Berard
Lyon, 69008
CHU Poitiers
Poitiers, 86000
IUCT Oncopôle
Toulouse, 31059
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: 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
Read the 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
- Being tested
- Association of berzosertib with gemcitabine, Gemcitabine
- Keywords
- ATR inhibition, soft-tissue sarcoma, advanced/metastatic
- Medical subject headings
- Leiomyosarcoma, Sarcoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Association of berzosertib with gemcitabineDrug
Also called Experimental
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.
GemcitabineDrug
Also called Control
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm A: treatment by berzosertib combined with gemcitabine | Experimental | Patients with advanced leiomyosarcomas will be treated with berzosertib combined with gemcitabine Receives: Drug: Association of berzosertib with gemcitabine |
| Standard Arm B: treatment by gemcitabine alone | Other | Patients with advanced leiomyosarcomas will be treated with with gemcitabine alone (control arm) Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the antitumor activity of berzosertib combined with gemcitabine
Antitumor activity will be assessed in terms of 6-month progression-free rate and is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST v1.1.
Measured: 6 months
Assessment of the antitumor activity of gemcitabine
Antitumor activity will be assessed in terms of 6-month progression-free rate and is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST v1.1.
Measured: 6 months
Secondary outcomes (19)
6-month objective response rate (ORR) for patients treated by berzosertib in association with gemcitabine
Objective response is defined as complete response (CR) or partial response (PR) as per adapted RECIST v1.1.
Measured: 6 months
6-month objective response rate (ORR) for patients treated by gemcitabine alone
Objective response is defined as complete response (CR) or partial response (PR) as per adapted RECIST v1.1.
Measured: 6 months
Best overall response for patients treated by berzosertib in association with gemcitabine
Best overall response is defined as the best reponse across all time points (RECIST v1.1). The best overall response rate is determined once all the data for the patient is known
Measured: throughout the treatment period, an expected average of 6 months
Best overall response for patients treated by gemcitabine alone
Best overall response is defined as the best reponse across all time points (RECIST v1.1). The best overall response rate is determined once all the data for the patient is known
Measured: throughout the treatment period, an expected average of 6 months
1-year progression-free survival for patients treated by berzosertib in association with gemcitabine
Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST v1.1) or death (from any cause), whichever occurs first
Measured: 1 year
1-year progression-free survival for patients treated by gemcitabine alone
Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST v1.1) or death (from any cause), whichever occurs first
Measured: 1 year
2-year progression-free survival for patients treated by berzosertib in association with gemcitabine
Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST v1.1) or death (from any cause), whichever occurs first
Measured: 2 years
2-year progression-free survival for patients treated by gemcitabine alone
Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST v1.1) or death (from any cause), whichever occurs first
Measured: 2 years
1-year overall survival for patients treated by berzosertib in association with gemcitabine
Overall survival is defined as the delay between the start date of treatment and the date of death (from any cause)
Measured: 1 year
1-year overall survival for patients treated by gemcitabine alone
Overall survival is defined as the delay between the start date of treatment and the date of death (from any cause)
Measured: 1 year
2-year overall survival for patients treated by berzosertib in association with gemcitabine
Overall survival is defined as the delay between the start date of treatment and the date of death (from any cause)
Measured: 2 years
2-year overall survival for patients treated by gemcitabine alone
Overall survival is defined as the delay between the start date of treatment and the date of death (from any cause)
Measured: 2 years
6-month objective response according to CHOI criteria, independently for each arm
Objective response is defined as complete response (CR) or partial response (PR) as per CHOI criteria.
Measured: 6 months
Best overall response according to CHOI criteria, independently for each arm
Best overall response is defined as the best reponse across all time points (CHOI criteria). The best overall response rate is determined once all the data for the patient is known
Measured: throughout the treatment period, an expected average of 6 months
Safety profile independently for each arm: Common Terminology Criteria for Adverse Event version 5
Toxicity graded using the Common Terminology Criteria for Adverse Events version 5
Measured: throughout the treatment period, an expected average of 6 months
Tumor immune cells levels
Levels of immune cells (CD4, CD8, PDL1)in tumor will be measured by immunohistochemistry
Measured: before treatment onset and cycle 2 day 1 (each cycle is 21 days)
Blood cytokines levels
Levels of cytokines (tryptophane, interleukine) in blood will be measured by ELISA
Measured: baseline, cycle 2 day 1, cycle 6 day 1 and progression (each cycle is 21 days)
Blood lymphocytes levels
Levels of fixed PBMC (peripheral blood mononucear cells) in blood will be measured by flow cytometry
Measured: baseline, cycle 2 day 1, cycle 6 day 1 and progression (each cycle is 21 days)
Blood kynurenine levels
Levels of kynurenine in blood will be measured by ELISA
Measured: baseline, cycle 2 day 1, cycle 6 day 1 and progression (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start9 Feb 2022
- Primary completion29 Sep 2024
- Study completion21 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leiomyosarcoma, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807816
- Sponsor's protocol ID
- IB 2018-04
- Other IDs
- 2018-003835-31, 2018
- Acronym
- TARSARC
- Status last verified
- May 2026
- First submitted
- 15 Mar 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting ATR in Soft-tissue Sarcomas: a Randomized Phase II Study. TARSARC Study
- ClinicalTrials.gov ID
- NCT04807816
- Acronym / sponsor ID
- TARSARC / IB 2018-04
- Conditions
- Leiomyosarcoma, Adult
- Keywords
- ATR inhibition, soft-tissue sarcoma, advanced/metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 29 Sep 2024 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm A: treatment by berzosertib combined with gemcitabine | Experimental | Drug: Association of berzosertib with gemcitabinePatients with advanced leiomyosarcomas will be treated with berzosertib combined with gemcitabine |
| Standard Arm B: treatment by gemcitabine alone | Other | Drug: GemcitabinePatients with advanced leiomyosarcomas will be treated with with gemcitabine alone (control arm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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,
Key exclusion criteria (24 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Association of berzosertib with gemcitabineAlso: ExperimentalGemcitabine 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 | Experimental Arm A: treatment by berzosertib combined with gemcitabine |
| GemcitabineAlso: ControlGemcitabine 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. | Drug | Standard Arm B: treatment by gemcitabine alone |
Primary outcome
Assessment of the antitumor activity of berzosertib combined with gemcitabine
Time frame: 6 months
Antitumor activity will be assessed in terms of 6-month progression-free rate and is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST v1.1.
Assessment of the antitumor activity of gemcitabine
Time frame: 6 months
Antitumor activity will be assessed in terms of 6-month progression-free rate and is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST v1.1.
19 secondary outcomes
6-month objective response rate (ORR) for patients treated by berzosertib in association with gemcitabine
Time frame: 6 months
6-month objective response rate (ORR) for patients treated by gemcitabine alone
Time frame: 6 months
Best overall response for patients treated by berzosertib in association with gemcitabine
Time frame: throughout the treatment period, an expected average of 6 months
Best overall response for patients treated by gemcitabine alone
Time frame: throughout the treatment period, an expected average of 6 months
1-year progression-free survival for patients treated by berzosertib in association with gemcitabine
Time frame: 1 year
1-year progression-free survival for patients treated by gemcitabine alone
Time frame: 1 year
2-year progression-free survival for patients treated by berzosertib in association with gemcitabine
Time frame: 2 years
2-year progression-free survival for patients treated by gemcitabine alone
Time frame: 2 years
1-year overall survival for patients treated by berzosertib in association with gemcitabine
Time frame: 1 year
1-year overall survival for patients treated by gemcitabine alone
Time frame: 1 year
2-year overall survival for patients treated by berzosertib in association with gemcitabine
Time frame: 2 years
2-year overall survival for patients treated by gemcitabine alone
Time frame: 2 years
6-month objective response according to CHOI criteria, independently for each arm
Time frame: 6 months
Best overall response according to CHOI criteria, independently for each arm
Time frame: throughout the treatment period, an expected average of 6 months
Safety profile independently for each arm: Common Terminology Criteria for Adverse Event version 5
Time frame: throughout the treatment period, an expected average of 6 months
Tumor immune cells levels
Time frame: before treatment onset and cycle 2 day 1 (each cycle is 21 days)
Blood cytokines levels
Time frame: baseline, cycle 2 day 1, cycle 6 day 1 and progression (each cycle is 21 days)
Blood lymphocytes levels
Time frame: baseline, cycle 2 day 1, cycle 6 day 1 and progression (each cycle is 21 days)
Blood kynurenine levels
Time frame: baseline, cycle 2 day 1, cycle 6 day 1 and progression (each cycle is 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Association of berzosertib with gemcitabine and Gemcitabine in people with Leiomyosarcoma, Adult, run by Institut Bergonié at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the antitumor activity of berzosertib combined with gemcitabine (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.