tTF-NGR Randomized Study - STS
ConditionSoft Tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversität Münster
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 contraindications to these drugs
Dedifferentiated liposarcoma
Myxoid liposarcoma (high grade)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Trabectedin
DrugPatients will receive standard trabectedin 1.5 mg/m2 as a 24-hour central intravenous (IV) infusion on day 1, q d 22 x until disease progression or contraindications against further application.
tTF-NGR
Biological/VaccinePatients will receive standard trabectedin according to arm 1 plus 0.5 mg/m2 of tTF-NGR (1-hour ratecontrolled infusion, port central venous access, 0.9 % NaCl ad 100 mL) on days 2 and 3 following each trabectedin cycle (within 1 hour interval between end of trabectedin infusion and tTF-NGR: e.g.: trabectedin on monday 8 am to tuesday 8 am followed by tTF-NGR on tuesday 9 am and on the following day, q d 22 x until disease progression or contraindications against further application.
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Standard chemotherapy with trabectidin (in-label)Active comparator 1 intervention
Group B: Arm 2: tTF-NGR added to standard trabectedinExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Efficacy: Prolongation of progression-free survival (PFS) according to iRECIST as judged by central radiology in a blinded fashion after end of trial.
The primary objective of the trial is to evaluate whether tTF-NGR in combination with standard trabectedin chemotherapy given for unresectable or metastatic soft tissue sarcoma after failure of anthracycline-containing first line therapy or with contraindications to these drugs prolongs progression-free survival, as compared with trabectedin alone. The following efficacy endpoint (for the randomized phase III part) will be considered: \- Progression-free survival (PFS) according to iRECIST (Seymour L, Lancet Oncol. 2017) as judged by central radiology in a blinded fashion after end of trial.
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsSecondary outcomes
1
Evaluation of the efficacy of tTF-NGR in combination with standard trabectedin chemotherapy (OOR)
To assess the efficacy, the following measurement will be considered: Overall response rate (ORR, consisting of CR and PR)
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months2
Evaluation of the efficacy of tTF-NGR in combination with standard trabectedin chemotherapy (DCR)
To assess the efficacy, the following measurement will be considered: \- Disease control rate (DCR, consisting of CR, PR, and stable disease (SD) for \>18 weeks)
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months3
Evaluation of the efficacy of tTF-NGR in combination with standard trabectedin chemotherapy (mPFS)
To assess the efficacy, the following measurement will be considered: \- Median progression-free survival (mPFS)
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months4
Evaluation of the efficacy of tTF-NGR in combination with standard trabectedin chemotherapy (mOS)
To assess the efficacy, the following measurement will be considered: \- Median overall survival (mOS)
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universität Münster
Lead sponsor
Anturec Pharmaceuticals GmbH
Collaborator
Source ClinicalTrials.gov