Soft-tissue SarcomasPhase 1/2TARMICNCT02805725
Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly Trabectedin Combined With Metronomic Cyclophosphamide
A Phase 1/2 study testing Phase 1: Trabectedin, Phase 2: Trabectedin and Phase 1: Cyclophosphamide in people with Soft-tissue Sarcomas, run by Institut Bergonié at 1 site in France.
Trial summary
Assessment of the efficacy and safety of trabectedin and metronomic cyclophosphamide (CP) in patients with advanced pretreated soft-tissue sarcomas, once the Maximum Tolerated Dose (MTD) have been determined (phase I trial). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft-tissue Sarcomas
- What is being tested?
- Phase 1: Trabectedin, Phase 2: Trabectedin and Phase 1: Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Dec 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with soft-tissue sarcoma histologically confirmed by central review
- Metastatic or unresectable locally advanced disease,
- Age ≥ 18 years,
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2,
- Life expectancy > 3 months,
- Measurable disease according to RECIST v1.1 outside any previously irradiated field,
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- For patients included in phase II study, progressive disease according to RECIST v1.1 criteria diagnosed on the basis of two CT scan or MRI obtained at an interval less than 6 months in the period of 12 months prior to inclusion and confirmed by central review,
- Previous use of Anthracyclines,
- Have provided tissue from an archival tissue sample,
- At least three weeks since last chemotherapy, immunotherapy or any other pharmacological treatment and/or radiotherapy,
- Adequate hematological, renal, metabolic and hepatic function:
- Hemoglobin ≥ 9 g/dl (patients may have received prior red blood cell [RBC] transfusion, if clinically indicated); absolute neutrophil count (ANC) ≥ 1.5 x 10^9/l, and platelet count ≥ 100 x 10^9/l
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST)< or = 2.5 x upper limit of normality (ULN) ( < or = 5 in case of extensive liver involvement) and alkaline phosphatase (AP) < or = 2.5 x ULN
- Total bilirubin < or = ULN.
- Albumin ≥ 25 g/l
- Serum Creatinine < or =1.5 x ULN or calculated creatinine clearance (CrCl) ≥ 30 ml/min (according to Cockroft formula).
- Creatine Phosphokinase (CPK) < or = 2.5 x ULN
- Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six months after discontinuation of treatment. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant and double barrier,
- 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 (excluding alopecia of any grade and non-painful peripheral neuropathy grade ≤ 2) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.0),
- Patients with a French social security in compliance with the Law relating to biomedical research (Article 1121-11 of French Public Health Code),
- Voluntarily signed and dated written informed consent prior to any study specific procedure.
Who cannot join
- Previous treatment with Trabectedin,
- Currently active bacterial or fungus infection (> grade 2 CTC [CTCAE] HIV1, HIV2, hepatitis B or hepatitis C infections,
- History of chronic alcohol use and/or cirrhosis,
- The following unstable cardiac conditions are not allowed:
- Congestive heart failure
- Angina pectoris
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- Myocardial infarction within 1 year before registration
- Uncontrolled arterial hypertension defined as blood pressure ≥ 150/100 mmHg despite optimal medical therapy
- Arrhythmias clinically significant
- Patients unable to receive corticotherapy,
- Known central nervous system malignancy (CNS),
- Men or women of childbearing potential who are not using an effective method of contraception as previously described; 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.
- Recent vaccination (in the last 2 weeks before inclusion) for yellow fever.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly Trabectedin Combined With Metronomic Cyclophosphamide (CP) in Patients With Advanced Pretreated Soft-tissue Sarcomas. A Phase I/II Study From the French Sarcoma Group.
Assessment of the efficacy and safety of trabectedin and metronomic cyclophosphamide (CP) in patients with advanced pretreated soft-tissue sarcomas, once the Maximum Tolerated Dose (MTD) have been determined (phase I trial).
Read the detailed description
Phase I: Multicenter Phase I trial based on a dose escalation study design (3+3 traditional design). Phase II: One-arm, multicenter Phase II trial based on two-stage optimal Simon's design.
- Conditions
- Soft-tissue Sarcomas
- Being tested
- Phase 1: Trabectedin, Phase 2: Trabectedin, Phase 1: Cyclophosphamide, Phase 2: Cyclophosphamide
- Keywords
- Advanced solid tumor, Advanced pretreated soft tissue sarcomas, Phase I/II trial, Dose escalation, PK study
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1: TrabectedinDrug
Phase I trial based on a dose escalating study design (3+3 traditional design) assessing four dose levels of Trabectedin in combination with metronomic cyclophosphamide (CP).
A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)
Phase 2: TrabectedinDrug
Patients will be included in a single-arm phase II trial. Administrated dose will be the RP2D defined in the dose escalation part of the trial. The design will follow a two-stage Simon's optimal design.
All patients will be treated at the RP2D of trabectedin defined in the preliminary phase I trial with the same schedule as in the phase I trial.
Phase 1: CyclophosphamideDrug
A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.
Phase 2: CyclophosphamideDrug
All patients will be treated with metronomic cyclophosphamide with the same schedule as in the phase I trial.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Trabectedin 0.30 mg/m2 IV + CP | Experimental | Trabectedin 0.30 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 1 of dose escalation.
Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.
1 cycle = 28 days Receives: Drug: Phase 1: Trabectedin; Drug: Phase 1: Cyclophosphamide |
| Cohort 2: Trabectedin 0.40 mg/m2 IV + CP | Experimental | Trabectedin 0.40 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 2 of dose escalation.
Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.
1 cycle = 28 days Receives: Drug: Phase 1: Trabectedin; Drug: Phase 1: Cyclophosphamide |
| Cohort 3: Trabectedin 0.50 mg/m2 IV + CP | Experimental | Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 3 of dose escalation.
Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.
1 cycle = 28 days Receives: Drug: Phase 1: Trabectedin; Drug: Phase 1: Cyclophosphamide |
| Cohort 4: Trabectedin 0.60 mg/m2 IV + CP | Experimental | Trabectedin 0.60 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 4 of dose escalation.
Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.
1 cycle = 28 days Receives: Drug: Phase 1: Trabectedin; Drug: Phase 1: Cyclophosphamide |
| Phase II: Trabectedin 0.50 mg/m2 IV + CP | Experimental | Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in the phase II part of the study.
Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.
1 cycle = 28 days Receives: Drug: Phase 2: Trabectedin; Drug: Phase 2: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Maximum Tolerated Dose (MTD) of Trabectedin When Administered in Association With CP.
MTD was determined by testing increasing doses of trabectedin up to 0.60 mg/m2 via IV on dose escalation cohorts 1 to 4 with 3 to 6 participants each.The MTD is defined as the highest dose at which no more than 1 in 6 of the patients in the cohort experienced a DLT in the first treatment cycle. See subsequent primary outcome measure for the DLT definition.
Measured: During the first cycle (28 days)
Phase I: Number of Patients Who Experienced Dose-Limiting Toxicities (DLTs)
A DLT was defined as a treatment-related (at least possibly related) adverse event using the CTCAE V4.0, occuring during the fist cycle of treatment (28 days), that meets one of the following criteria:
- Any grade-4 toxicity (except for vomiting without maximal symptomatic/prophylactic treatment)
- Grade-3 non-haematological toxicity lasting > 7days (except for 1rst episode of nausea without maximal symptomatic/ prophylactic treatment and if toxicity is transaminitis, which may last > 7 days if total bilirubin is normal or grade-1)
- Grade-3 hematologic toxicity lasting for > 7days
- Grade 4 neutropenia with fever
- Grade > 2 thrombocytopenia with bleeding
- Is unrelated to disease, disease progression, inter-current illness, or concomitant medications.
Measured: During the first cycle (28 days)
Phase II: Percentage of Patients in Non-progression at 6 Months (RECIST V1.1)
Non-progression is defined as complete or partial response (CR, PR) or stable disease (SD), as per RECIST v1.1. According to RECIST v1.1: Complete Response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as a >=30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at baseline (SSD); Stable disease (SD) is defined as Neither sufficient shrinkage (compared to baseline) to qualify for PR or CR nor sufficient increase (taking as reference the SSD or while on study, whichever is smallest) to qualify for progressive disease (PD).
Measured: Phase II : 6 months after the start of treatment
Secondary outcomes (3)
Phase I: Percentage of Patients With Objective Response (RECIST V1.1)
Objective response is defined as complete or partial response (CR, PR) as per RECIST v1.1. According to RECIST v1.1: Complete Response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as a >=30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at baseline (SSD).
Measured: Throughout the treatment period, an average of 6 months
Phase II: Median Overall Survival
Overall survival is defined as the time from the study initiation to death (any cause). Median overall survival was reported using kaplan-Meier method for calculation.
Measured: From start of treatment, and during treatment until death for any cause for up to 12 months.
Phase II: Median Profression-free Survival
Progression-free survival is defined as the time from study treatment initiation to disease progression or death (of any cause), whichever occurs first. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), or a unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. Median PFS was reported using kaplan-Meier method for calculation.
Measured: From start of treatment, and during treatment until progression or death for any cause for up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startDec 2015
- Primary completionApr 2020
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Soft-tissue SarcomasStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- PharmaMar
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805725
- Sponsor's protocol ID
- IB 2015-04
- Acronym
- TARMIC
- Status last verified
- Jan 2026
- First submitted
- 25 May 2016
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly Trabectedin Combined With Metronomic Cyclophosphamide (CP) in Patients With Advanced Pretreated Soft-tissue Sarcomas. A Phase I/II Study From the French Sarcoma Group.
- ClinicalTrials.gov ID
- NCT02805725
- Acronym / sponsor ID
- TARMIC / IB 2015-04
- Conditions
- Soft-tissue Sarcomas
- Keywords
- Advanced solid tumor, Advanced pretreated soft tissue sarcomas, Phase I/II trial, Dose escalation, PK study
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- PharmaMar
- Study start
- Dec 2015 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Posted 23 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the efficacy and safety of trabectedin and metronomic cyclophosphamide (CP) in patients with advanced pretreated soft-tissue sarcomas, once the Maximum Tolerated Dose (MTD) have been determined (phase I trial).
Detailed description
Phase I: Multicenter Phase I trial based on a dose escalation study design (3+3 traditional design). Phase II: One-arm, multicenter Phase II trial based on two-stage optimal Simon's design.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Trabectedin 0.30 mg/m2 IV + CP | Experimental | Drug: Phase 1: Trabectedin, Drug: Phase 1: CyclophosphamideTrabectedin 0.30 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 1 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days |
| Cohort 2: Trabectedin 0.40 mg/m2 IV + CP | Experimental | Drug: Phase 1: Trabectedin, Drug: Phase 1: CyclophosphamideTrabectedin 0.40 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 2 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days |
| Cohort 3: Trabectedin 0.50 mg/m2 IV + CP | Experimental | Drug: Phase 1: Trabectedin, Drug: Phase 1: CyclophosphamideTrabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 3 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days |
| Cohort 4: Trabectedin 0.60 mg/m2 IV + CP | Experimental | Drug: Phase 1: Trabectedin, Drug: Phase 1: CyclophosphamideTrabectedin 0.60 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 4 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days |
| Phase II: Trabectedin 0.50 mg/m2 IV + CP | Experimental | Drug: Phase 2: Trabectedin, Drug: Phase 2: CyclophosphamideTrabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in the phase II part of the study. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients with soft-tissue sarcoma histologically confirmed by central review
- Metastatic or unresectable locally advanced disease,
- Age ≥ 18 years,
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2,
- Life expectancy > 3 months,
Key exclusion criteria (17 listed)
- Previous treatment with Trabectedin,
- Currently active bacterial or fungus infection (> grade 2 CTC [CTCAE] HIV1, HIV2, hepatitis B or hepatitis C infections,
- History of chronic alcohol use and/or cirrhosis,
- The following unstable cardiac conditions are not allowed:
- Patients unable to receive corticotherapy,
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 |
|---|---|---|
| Phase 1: TrabectedinPhase I trial based on a dose escalating study design (3+3 traditional design) assessing four dose levels of Trabectedin in combination with metronomic cyclophosphamide (CP). A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) | Drug | Cohort 1: Trabectedin 0.30 mg/m2 IV + CP, Cohort 2: Trabectedin 0.40 mg/m2 IV + CP, Cohort 3: Trabectedin 0.50 mg/m2 IV + CP, Cohort 4: Trabectedin 0.60 mg/m2 IV + CP |
| Phase 2: TrabectedinPatients will be included in a single-arm phase II trial. Administrated dose will be the RP2D defined in the dose escalation part of the trial. The design will follow a two-stage Simon's optimal design. All patients will be treated at the RP2D of trabectedin defined in the preliminary phase I trial with the same schedule as in the phase I trial. | Drug | Phase II: Trabectedin 0.50 mg/m2 IV + CP |
| Phase 1: CyclophosphamideA treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. | Drug | Cohort 1: Trabectedin 0.30 mg/m2 IV + CP, Cohort 2: Trabectedin 0.40 mg/m2 IV + CP, Cohort 3: Trabectedin 0.50 mg/m2 IV + CP, Cohort 4: Trabectedin 0.60 mg/m2 IV + CP |
| Phase 2: CyclophosphamideAll patients will be treated with metronomic cyclophosphamide with the same schedule as in the phase I trial. | Drug | Phase II: Trabectedin 0.50 mg/m2 IV + CP |
Primary outcome
Phase I: Maximum Tolerated Dose (MTD) of Trabectedin When Administered in Association With CP.
Time frame: During the first cycle (28 days)
MTD was determined by testing increasing doses of trabectedin up to 0.60 mg/m2 via IV on dose escalation cohorts 1 to 4 with 3 to 6 participants each.The MTD is defined as the highest dose at which no more than 1 in 6 of the patients in the cohort experienced a DLT in the first treatment cycle. See subsequent primary outcome measure for the DLT definition.
Phase I: Number of Patients Who Experienced Dose-Limiting Toxicities (DLTs)
Time frame: During the first cycle (28 days)
A DLT was defined as a treatment-related (at least possibly related) adverse event using the CTCAE V4.0, occuring during the fist cycle of treatment (28 days), that meets one of the following criteria: * Any grade-4 toxicity (except for vomiting without maximal symptomatic/prophylactic treatment) * Grade-3 non-haematological toxicity lasting > 7days (except for 1rst episode of nausea without maximal symptomatic/ prophylactic treatment and if toxicity is transaminitis, which may last > 7 days if total bilirubin is normal or grade-1) * Grade-3 hematologic toxicity lasting for > 7days * Grade 4 neutropenia with fever * Grade > 2 thrombocytopenia with bleeding * Is unrelated to disease, disease progression, inter-current illness, or concomitant medications.
Phase II: Percentage of Patients in Non-progression at 6 Months (RECIST V1.1)
Time frame: Phase II : 6 months after the start of treatment
Non-progression is defined as complete or partial response (CR, PR) or stable disease (SD), as per RECIST v1.1. According to RECIST v1.1: Complete Response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as a >=30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at baseline (SSD); Stable disease (SD) is defined as Neither sufficient shrinkage (compared to baseline) to qualify for PR or CR nor sufficient increase (taking as reference the SSD or while on study, whichever is smallest) to qualify for progressive disease (PD).
3 secondary outcomes
Phase I: Percentage of Patients With Objective Response (RECIST V1.1)
Time frame: Throughout the treatment period, an average of 6 months
Phase II: Median Overall Survival
Time frame: From start of treatment, and during treatment until death for any cause for up to 12 months.
Phase II: Median Profression-free Survival
Time frame: From start of treatment, and during treatment until progression or death for any cause for up to 12 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Phase 1: Trabectedin, Phase 2: Trabectedin and Phase 1: Cyclophosphamide in people with Soft-tissue Sarcomas, run by Institut Bergonié at 1 site 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 22 inclusion and 17 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 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 23 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Phase I: Maximum Tolerated Dose (MTD) of Trabectedin When Administered in Association With CP. (time frame: During the first cycle (28 days)). The study lists 3 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 14 Jan 2026.