Unresectable or metastatic conventional chondrosarcoma
Conditions
Brief summary
Progression Free Survival (PFS) per RECISTv1.1 assessed by central IRR in the ITT population
Detailed description
Overall Survival (OS) in the ITT Population, ORR per RECISTv1.1 by central real-time IRR., PFS per RECISTv1.1 by Investigator assessment., QoL per EORTC QLQ-C30 (Pain and Physical Function)., DCR per RECISTv1.1 by central real-time IRR., DOR per RECISTv1.1 by central real-time IRR., Treatment emergent adverse events (TEAEs) including Serious adverse event (SAEs)., PK characterization: AUC0-inf, AUC0-last, AUC0-21d, Cmax, Ctrough, Tmax will be estimated using a standard non-compartmental method as the data allow. Other PK parameters (λz, t½, Vd, CL, and accumulation ratios RCmax, RCtrough) will be calculated if data permit., Frequency of ADAs and Nabs.
Interventions
DRUGGLUCOSE
DRUGACETYLCYSTEINE
DRUGDEXAMETHASONE
DRUGDIPHENHYDRAMINE
Sponsors
Inhibrx Biosciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) per RECISTv1.1 assessed by central IRR in the ITT population | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) in the ITT Population, ORR per RECISTv1.1 by central real-time IRR., PFS per RECISTv1.1 by Investigator assessment., QoL per EORTC QLQ-C30 (Pain and Physical Function)., DCR per RECISTv1.1 by central real-time IRR., DOR per RECISTv1.1 by central real-time IRR., Treatment emergent adverse events (TEAEs) including Serious adverse event (SAEs)., PK characterization: AUC0-inf, AUC0-last, AUC0-21d, Cmax, Ctrough, Tmax will be estimated using a standard non-compartmental method as the data allow. Other PK parameters (λz, t½, Vd, CL, and accumulation ratios RCmax, RCtrough) will be calculated if data permit., Frequency of ADAs and Nabs. | — |
Countries
France, Germany, Ireland, Italy, Netherlands, Spain
Outcome results
None listed