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.

Sarcoma, Soft Tissue

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.

Olaratumab and Trabectedin

Dose-escalation levels:
LEVEL 2: Olaratumab 15 mg/Kg D1 and D8 + Trabectedin 1.5 mg/m2 D1

Dose-escalation levels:
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 the 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)) and then, the maintenance dose will be 15 mg/m2 for the rest of cycles.

GEIS

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

Phase I Clinical Trial of Olaratumab Plus Trabectedin in Advanced Soft-tissue Sarcoma Patients

There will be determined the security profile for each dose level.

Objective Response Rate (ORR): ORR is defined as the number of subjects with a Best Overall Response (BOR) according to RECIST 1.1.

Correlation of clinical outcome with translational biomarkers (See Translational Section)

QoL measured per QLQ-C30 questionnaire of EORTC.

We are open to Individual participant data (IPD). Whenever there is a researcher interested in OLATRASTS raw data results, please contact the Study Chief to comment on the objectives and agreement of this sharing.

Grupo Espanol de Investigacion en Sarcomas

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. See chapter 5 for more details.
Treatment is a combination of unlimited cycles of oralatumab and trabectedin.

Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards.

Placebo

Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.

Liraglutide 1.8mg

Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.

Liraglutide 1.2mg

Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.

Liraglutide 0.6 mg

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Age of Type 1 Diabetes Diagnosis

The primary endpoint of the study is to detect a difference from baseline in mean weekly blood glucose concentrations before and after 12 weeks of treatment in each of the Liraglutide groups.

Change in Mean Weekly Glucose Concentrations From Baseline at 12 Weeks

Change in HbA1c From Baseline at 12 Weeks

Change in Body Weight From Baseline at Week 12

Total insulin dose = Basal insulin dose plus bolus insulin dose.

Change in Total Insulin Dose From Baseline at 12 Weeks

Percent Time Spent in Hyperglycemia and Hypoglycemia

Reduction in the Area Under Curve(AUC) of Glucose Following the Meal

Serum Acetaminophen Concentrations Following Meal Challenge

Carbohydrate Intake

Insulin, C-peptide, Glucagon, GLP-1(Glucagon Like Peptide-1) and GIP(Gastric Inhibitory Polypeptide) Concentrations Following Meal Challenge.

Overall Study

Nitesh D Kuhadiya,MD,MPH ;Co-Investigator;Assistant Professor of Medicine, Section of Endocrinology

Type 1 Diabetes

Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.

Liraglutide

Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards.

fibrosarcoma/غثيان

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

Liraglutide in the Treatment of Type 1 Diabetes Mellitus

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