Actively Recruiting
tTF-NGR Randomized Study - STS
Led by Universität Münster · Updated on 2025-04-04
126
Participants Needed
9
Research Sites
266 weeks
Total Duration
On this page
Sponsors
U
Universität Münster
Lead Sponsor
A
Anturec Pharmaceuticals GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Before the randomized phase III part of the study, there was a safety run-in part. The final dose of tTF-NGR established as safe in this safety run-in part is 0.5 mg/m2 per day for 2 consecutive days following each trabectedin infusion and is used for the randomized (parallel 1:1; Arm 1: standard trabectedin, Arm 2: standard trabectedin plus tTF-NGR) phase III part of this trail. . Further dose modification for tTF-NGR is possible.
CONDITIONS
Official Title
tTF-NGR Randomized Study - STS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years of any gender
- Advanced or metastatic soft tissue sarcoma after failure of anthracycline-containing first line or adjuvant therapy within 12 months or with contraindications to anthracyclines
- Histological confirmation of high-grade (grade 2-3) unresectable or metastatic soft tissue sarcoma of specified types (e.g., dedifferentiated liposarcoma, myxoid liposarcoma, leiomyosarcoma, others) or with approval from Coordinating Investigator
- CD13 positivity with a score of 1 or higher by central pathology
- At least one measurable lesion by CT or MRI not previously irradiated
- Life expectancy of at least 3 months
- ECOG performance status 0 to 2
- No contraindications for trabectedin
- Negative pregnancy test for females of childbearing potential within 14 days before treatment
- Signed informed consent
- Willingness and ability to comply with study visits, treatments, and tests
- Women of childbearing potential must use highly effective contraception during and 3 months after treatment; men must use contraception for 5 months after treatment
You will not qualify if you...
- Availability of curative therapy
- Significant unrelated illness compromising ability to tolerate treatment or study procedures
- Immobilized patients with increased risk of deep vein thrombosis
- Known hypersensitivity to E. coli-derived materials
- History of coronary heart disease, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis
- Known hereditary syndromes or vascular disorders with high thromboembolic risk
- Khorana score greater than 3
- Elevated Troponin T or I before study entry
- Active central nervous system disease or vascular abnormalities
- Inadequate bone marrow, renal, or liver function
- Abnormal coagulation parameters (fibrinogen below 150 mg/dL or INR above 1.5)
- Female patients who refuse pregnancy testing or contraception
- Breastfeeding women
- Use of other investigational or anti-cancer agents
- Participation in other clinical trials interfering with this study
- Any medical condition that compromises study participation
- Recent use of anticoagulation within 3 days
- Active uncontrolled infections or severe concurrent diseases
- Other cancers unless disease-free for at least 2 years
- Serious non-healing wounds or recent surgeries
- No central venous port system in place unless approved by Coordinating Investigator
AI-Screening
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Trial Site Locations
Total: 9 locations
1
HELIOS Klinikum Bad Saarow
Bad Saarow, Germany, 15529
Actively Recruiting
2
HELIOS Klinikum Berlin-Buch
Berlin, Germany, 13125
Actively Recruiting
3
TU Dresden Medizinische Fakultät Carl Gustav Carus
Dresden, Germany, 01307
Actively Recruiting
4
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
5
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
6
Universitätsmedizin Mainz
Mainz, Germany, 55131
Actively Recruiting
7
Klinikum rechts der Isar der technischen Universität München
München, Germany, 81675
Actively Recruiting
8
LMU Klinikum
Münich, Germany, 81377
Actively Recruiting
9
University Hospital Muenster, Germany
Münster, Germany, 48149
Actively Recruiting
Research Team
C
Christoph Schliemann, Prof. Dr.
CONTACT
T
Torsten Kessler, PD Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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