Olaratumab and Doxorubicin in Soft Tissue Sarcoma (JGDM)
Research type
Research Study
Full title
A Phase 1b Trial to Assess the Modulation of Biological Markers in Patients with Advanced Potentially Resectable Soft Tissue Sarcoma Treated with Olaratumab Monotherapy Followed by Olaratumab plus Doxorubicin Combination Therapy
IRAS ID
205464
Contact name
Thanos Konstantakopoulos
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2015-005018-31
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
Soft tissue sarcomas (STS) are cancers that develop from cells in the soft, supporting tissues of the body including muscle, fat, and fibrous tissue. STS is rare, comprising approximately 1% of adult cancers. When the disease is localised, it is usually treated using surgery with or without radiotherapy and/or chemotherapy. Unfortunately, STS recurs frequently as locally inoperable or metastatic disease, at which time doxorubicin chemotherapy is considered the standard treatment option for most patients.
In a previous Eli Lilly and Company, Phase 1b/2 trial (I5B-IE-JGDG), patients treated with olaratumab and doxorubicin, compared to those treated with only doxorubicin, achieved a higher median progression-free survival (time patient lives with the disease but it does not get worse). Olaratumab is a human antibody that binds to platelet-derived growth factor receptors, blocking the pathways which may result in tumour cell growth and spread of the cancer.
This study, I5B-MC-JGDM, is an open-label, single-arm, global, phase 1b trial that will enrol around 35 patients and last approximately 2.5 years. The study will assess the changes in circulating tumour cells in the blood and characterise the changes to platelet-derived growth factor receptors in the tumour cells, before and after taking the study drug, olaratumab. This will provide information to help with the understanding of how olaratumab works to stop / slow down cancer spread. To be eligible to participate in this study, patients must have STS and be a potential candidate for surgery and have a primary tumour deemed suitable for serial biopsy. Study assessments will include: physical examinations, questionnaire completion, blood tests, biopsies, ECG and radiological scans (CT, MRI, PET.)
REC name
London - South East Research Ethics Committee
REC reference
16/LO/1247
Date of REC Opinion
27 Jul 2016
REC opinion
Favourable Opinion