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New treatment option for Soft Tissue Sarcoma
Official title tTF-NGR Randomized Study - STS
ClinicalTrials.gov ID: NCT05597917
What this study is testing
What is Trabectedin?
Trabectedin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for soft tissue sarcoma.
Also referred to as Yondelis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In this phase III open label, controlled clinical trial patients with unresectable or metastatic soft-tissue sarcoma after failure of anthracycline-containing first line therapy or with contraindications to these drugs and CD13 positivity in central histology (grade \>/= 1+) are treated to evaluate whether tTF-NGR in combination with standard trabectedin chemotherapy prolongs progression-free survival (according to iRECIST), as compared with trabectedin alone. Further objectives are to evaluate the efficacy of tTF-NGR in combination with standard trabectedin chemotherapy with respect to the response rate and overall survival as well as to assess the safety profile of tTF-NGR combined with trabectedin.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients of all genders (female, male, diverse), with no restriction regarding ethnic or religious background age 18 - 75 years.
- Patients with advanced or metastatic soft-tissue sarcoma after failure of anthracycline-containing first line therapy (or anthracycline-containing...
- Patients must have histological evidence of high-grade advanced unresectable or metastatic soft tissue sarcoma (grade 2 - 3) according to the FNCLCC...
- Dedifferentiated liposarcoma
- Myxoid liposarcoma (high grade)
You likely can't join if
- curative therapy available
- clinically significant unrelated illness, which in the judgement of the investigators could compromise the patient's ability to tolerate the IMP or...
- immobilized tumor patients (wheel chair etc.) with increased risk for DVT
- known hypersensitivity reactions to prior application of E. coli-derived material
- history of coronary heart disease, stroke, transitent ischemic attacks, pulmonary embolism, or deep vein thrombosis. For reason of mechanism of...
- known hereditary syndromes with elevated thromboembolic risk (FV Leiden and prothrombin mutations (G20210A), hereditary antithrombin, protein C and S...
See the full eligibility criteria
Who can join
- Patients of all genders (female, male, diverse), with no restriction regarding ethnic or religious background age 18 - 75 years.
- Patients with advanced or metastatic soft-tissue sarcoma after failure of anthracycline-containing first line therapy (or anthracycline-containing adjuvant therapy within 12 months before entry on study) or with...
- Patients must have histological evidence of high-grade advanced unresectable or metastatic soft tissue sarcoma (grade 2 - 3) according to the FNCLCC grading system. The following tumor types are included:
- Dedifferentiated liposarcoma
- Myxoid liposarcoma (high grade)
- Pleomorphic liposarcoma
- Adult fibrosarcoma
- Myxofibrosarcoma (high-grade)
- Leiomyosarcoma
- Rhabdomyosarcoma (alveolar, pleomorphic)
- Angiosarcoma
- Synovial sarcoma
- Undifferentiated sarcoma Tumor types not listed above may be included upon communication with Coordinating Investigator. The following tumor types will not be included:
- Gastrointestinal stromal tumors (GIST)
- Epitheloid sarcoma
- Alveolar soft part sarcoma
- Desmoplastic small round cell tumor
- Chondrosarcoma
- Osteosarcoma
- Ewing sarcoma (including CIC-rearranged sarcoma and Sarcoma with BCOR alterations)
- CD13 positivity with a score of ≥ 1 (20) by central pathology (GDI Münster)
- Patients must have at least one unidimensionally measurable lesion by computed tomography as defined by RECIST criteria 1.1. Other adequate imaging procedures such as MRI are allowed. This lesion should not have been...
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- No contraindications for trabectedin (see attachment)
- Negative serum pregnancy test for females of childbearing potential\ within 14 days of starting treatment
- Informed consent signed and dated to participate in the study
- Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures
- Women of childbearing potential (WOCBP) must be using, from the screening to 3 months following the last trabectedin (Arm 1) or the last last study drug (Arm 2) administration, highly effective contraception methods, as...
What rules you out
- curative therapy available
- clinically significant unrelated illness, which in the judgement of the investigators could compromise the patient's ability to tolerate the IMP or be likely to interfere with the study procedures or results
- immobilized tumor patients (wheel chair etc.) with increased risk for DVT
- known hypersensitivity reactions to prior application of E. coli-derived material
- history of coronary heart disease, stroke, transitent ischemic attacks, pulmonary embolism, or deep vein thrombosis. For reason of mechanism of action of tTF-NGR, exclusion of patients with a history of any of the...
- known hereditary syndromes with elevated thromboembolic risk (FV Leiden and prothrombin mutations (G20210A), hereditary antithrombin, protein C and S deficiency, and antiphospholipid syndrome) after one or more clinical...
- patients with hereditary vascular disorders (such as Klippel-Trenauny-Weber syndrome) with increased thromboembolic risk.
- patients with a Khorana score of (Khorana AA, et al. J.Clin. Oncol. 2009, 27, 4839-4847, attached to this protocol) of \> 3
- elevated Troponin T hs (\> 50 ng/L) or elevated Troponin I hs before entry on study
- presence of active central nervous system (CNS) disease and/or CNS vascular abnormalities detected by MRI or CT
- no adequate bone marrow function, absolute neutrophil count (ANC) \< 1.0 x 109/L, platelets \< 50 x 109/L (for trabectedin actually \< 100 x 109/L - to be decided by the investigator on an individual patient basis) and...
- chronically impaired renal function or creatinine ≥ 2.0 x upper limit of normal (ULN).
- inadequate liver function (alanine aminotranserase (ALT), aspartate aminotranserase (AST), alkaline phosphatase (ALP) or total bilirubin ≥ 2.5 x ULN) unless due to liver metastasis (decision by the investigator)
- fibrinogen \ 1,5 (global coagulation parameters can be discussed with the Coordinating Investigator prior to entry on study)
- female patients with child-bearing who do not agree to exclusion of potential pregnancy by adequate testing within 48 hours prior to entry on study
- females of childbearing potential as well as fertile males who do not agree to use a highly effective form of contraception (Pearl Index \< 1) during the study and for 3 months (females) following the last trabectedin...
- women with breast-feeding activity
- concomitant use of any other investigational agent (agent for which there is currently no approved indication from regulatory authorities) or any other anti-cancer drug
- concomitant enrolment in another clinical trial interfering with the endpoints of this study.
- any medical condition which could compromise participation in the study according to the investigator's assessment.
- prophylactic or therapeutic anticoagulation within the last 3 days
- presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study
- concurrent malignancies other than STS, unless the patient has been disease-free for at least 2 years
- serious, non-healing wound, ulcer or bone fracture; not completed wound healing from previous wounds and/or surgery
- no central venous port system in place (the option of other central venous access than a port should be discussed with the Coordinating Investigator). NOTE: Outliers of laboratory values can be disregarded and set aside...
The study team makes the final eligibility decision.
Where it's taking place
- Bad Saarow, Germany
- Berlin, Germany
- Dresden, Germany
- Hanover, Germany
- Heidelberg, Germany
- Mainz, Germany
- München, Germany
- Münich, Germany
- Münster, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bad Saarow, Germany; Berlin, Germany; Dresden, Germany; Hanover, Germany; Heidelberg, Germany; Mainz, Germany and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.