Clinical Trial 18821

Cancer Type: Sarcoma
Interventions:Adriamycin (doxorubicin); Olaratumab; doxorubicin

Study Type: Treatment
Phase of Study: Phase I


    Study Title

    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.

    Inclusion Criteria

  • Have a histologically confirmed diagnosis of soft tissue sarcoma (STS) for which olaratumab and doxorubicin would be appropriate therapy. Participants with a diagnosis of Grade 1 liposarcoma are eligible if there is histological or radiographic evidence of evolution to more aggressive disease. Participants with Kaposi's sarcoma and gastrointestinal stromal tumors (GIST) will be excluded. Participants must have potentially resectable disease (as assessed by the study investigator) and have a primary tumor lesion deemed amenable to serial biopsy.
  • Have consented to undergo mandatory serial peripheral whole blood and tumor tissue sampling.

  • Exclusion Criteria

  • Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment. Participants with a history of a CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) that have not progressed on follow-up imaging, have been asymptomatic for at least 60 days and are not receiving systemic corticosteroids and or/anticonvulsants, are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before enrollment to rule out brain metastasis.
  • Have received prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines or anthracenediones; the participant has received treatment with olaratumab or has participated in a prior olaratumab trial.