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Clinical Trial 18821
Cancer Type: Sarcoma
Interventions:Adriamycin (doxorubicin); Olaratumab; doxorubicin
Study Type: Treatment
Phase of Study: Phase I
A Phase 1b Trial to Assess the Modulation of Biological Markers in Patients with Potentially Resectable Soft Tissue Sarcoma Treated with Olaratumab Monotherapy Followed by Olaratumab plus Doxorubicin Combination Therapy
The purpose of this study is to evaluate potential biomarkers and method of action, efficacy and safety of olaratumab in participants with soft tissue sarcoma (STS).
The Primary Objectives of this study are: To enumerate CTCs changes pre- and post-olaratumab monotherapy in whole blood in patients with potentially resectable STS. To characterize PDGFRÑ and platelet-derived growth factor receptor beta (PDGFRÒ) and canonical ligands (PDGF-A, B, C, and D) expression changes pre- and post-olaratumab monotherapy in tumor tissue in patients with potentially resectable STS. The Secondary Objectives of this study are: To evaluate any antitumor activity observed with olaratumab: - progression-free survival (PFS) and 3-month PFS - ORR (complete response [CR] + partial response [PR]) - disease control rate (DCR) (CR+ PR + stable disease [SD]) - rate of resectability. To evaluate the safety of olaratumab as assessed by reported AEs, clinical laboratory tests, vital signs, physical examinations, electrocardiograms (ECGs), and echocardiograms (ECHOs) or multi-gated acquisition (MUGA) scans. To evaluate the pharmacokinetics (PK) of olaratumab and immunogenicity (IG) parameters of olaratumab.