Spots Global Cancer Trial Database for OlaReDo - Olaratumab and Rechallenge With Doxorubicin in Soft Tissue Sarcoma Patients
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Trial Identification
Brief Title: OlaReDo - Olaratumab and Rechallenge With Doxorubicin in Soft Tissue Sarcoma Patients
Official Title: Efficacy of Olaratumab and Rechallenge With Doxorubicin in Anthracycline Pretreated, Advanced Soft Tissue Sarcoma Patients. An Exploratory Phase-II Study
Study ID: NCT03698227
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Salah-Eddin Al-Batran, Prof. Dr.
Affiliation: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Role: STUDY_DIRECTOR
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