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

NCT03985722 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-03-27

No results posted yet for this study

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

Conditions

  • Sarcoma, Soft Tissue

Interventions

DRUG

Olaratumab and Trabectedin

Dose escalation levels: LEVEL -1: Olaratumab 15 mg/Kg D1 and D8 + Trabectedin 0.9 mg/m2 D1 This is a security level in case level 0 causes DLT. LEVEL 0\*: Olaratumab 15 mg/Kg D1 and D8 + Trabectedin 1.1 mg/m2 D1. \* Dose starting level is 0. LEVEL 1: Olaratumab 15 mg/Kg D1 and D8 + Trabectedin 1.3 mg/m2 D1. LEVEL 2: Olaratumab 15 mg/Kg D1 and D8 + Trabectedin 1.5 mg/m2 D1. LEVEL 3\*\*: Olaratumab 20 mg/kg C1D1 and C1D8 (induction) + Trabectedin 1.5 mg/m2 D1 and Olaratumab 15 mg/kg D1 and D8 (maintenance) + Trabectedin 1.5 mg/m2 D1 \*\*In LEVEL 3, Olaratumab dose of 20 mg/kg will be considered only for the first 2 doses (as induction doses, cycle 1 days 1 and 8). Then, the maintenance dose will be 15 mg/m2 for the rest of cycles.

Sponsors & Collaborators

  • Grupo Espanol de Investigacion en Sarcomas

    lead OTHER

Principal Investigators

  • Javier MARTIN-BROTO, MD · University Hospital "Fundación Jiménez Díaz"

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-21
Primary Completion
2021-02-17
Completion
2024-05-05

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03985722 on ClinicalTrials.gov