Olaratumab Plus Trabectedin in Advanced Soft-tissue Sarcoma Patients Soft-tissue Sarcoma Patients

Summary

Phase I, multicentre clinical trial of olaratumab plus trabectedin in patients with advanced soft-tissue sarcoma. Olaratumab plus trabectedin could be synergistic and with a manageable toxicity profile in advanced STS. The study is a phase I, non-randomised, one-armed, multicenter trial, open-label. The dose escalation rules include patients in blocks of 3 o 6 patient. Treatment is a combination of unlimited cycles of oralatumab and trabectedin. Primary clinical study endpoint of phase I: \- Determine the maximum tolerated dose (MTD) or the recommended dose of olaratumab combined with trabectedin in advanced soft tissue sarcoma Secondary clinical study endpoints: * Objective Response Rate (ORR): ORR is defined as the number of subjects with a Best Overall Response (BOR) according to RECIST 1.1. * Progression free survival (PFS): time to progression or death from treatment initiation. * Overall survival (OS): Time from treatment initiation until death. Efficacy measured through tumor response according to Choi criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow-up until tumor progression. * Correlation of clinical outcome with translational biomarkers. * Quality of life (QoL) measured per QLQ-C30 questionnaire of EORTC

Timeline

Start

2018-09-21

Primary completion

2021-02-17

Completion

2024-05-05

Drugs

Indications