This is an exploratory, prospective, open label, single arm, phase II-study for the evaluation of efficacy and feasibility (as determined by safety and tolerability) of olaratumab and doxorubicin rechallenge in anthracycline pretreated locally advanced (unresectable) or metastatic soft tissue sarcoma patients.
Until now, rechallenge with anthracyclines in patients with metastatic STS which had a benefit from prior anthracycline containing therapy was never investigated in a prospective study. Due to the very promising effect of olaratumab and doxorubicin in anthracycline-naïve patients and further taking into consideration the results of the retrospective anthracycline rechallenge study, there is a clear rationale to evaluate the effects of olaratumab and doxorubicin also in anthracycline pretreated patients by conducting a prospective clinical trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Helios Klinikum Bad Saarow
Bad Saarow, Germany
Helios Klinikum Berlin-Buch Klinik für Onkologie und Palliativmedizin
Berlin, Germany
Charité Universitätsmedizin Berlin Medizinische Klinik m. S. Hämatologie, Onkologie und Tumorimmunologie Campus Virchow Kliniken
Berlin, Germany
Medizinische Fakultät Carl Gustav Carus Medizinische Klinik I Internistische Onkologie
Dresden, Germany
Progression-free survival rate after 3 months (PFSR3), assessed by applying RECIST 1.1
number of patients proven progression-free and alive after 3 months divided through the total number of patients in the all-treated-subjects population
Time frame: After 3 months treatment
Progression free survival (PFS)
Time from the first dosing date of any study medication to the date of the first Objectively documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause.
Time frame: 6 months of Follow Up
Objective response rate (ORR) (i.e. CR or PR)
Number and percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)
Time frame: 6 months of Follow Up
Disease control rate (DCR) (i.e. CR, PR or SD)
Number and percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD)
Time frame: 6 months of Follow Up
Overall survival (OS)
Time from date of the first dosing date of any study medication to the date of death (due to any cause)
Time frame: 6 months of Follow Up
Assessment of adverse events
Type, incidence and severity of AEs, SAEs
Time frame: During study conduct up to a maximum of 18 months (EOT)
Study therapy discontinuation rate due to cardiac toxicity
Number of patients proven study therapy discontinuation due to cardiac toxicity (i.e. due to LVEF reduction by more than 20% or LVEF \<45%) divided through the total number of patients in the all-treated-subjects population
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Time frame: After treatment discontinuation up to a maximum of 18 months (EOS)