Refractory Hematologic Malignancies or Solid Tumors
Conditions
Brief summary
1-year survival rate of patients treated on the Elraglusib schedule chosen from the run-in portion of the study compared to the control arm.
Detailed description
Disease control rate (DCR), defined as: Stable disease for ≥16 weeks, confirmed complete response, or confirmed partial response., Objective response rate (ORR), defined as the percent of patients with Complete Response (CR) or Partial Response (PR) according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) criteria relative to the efficacy population., Duration of Response (DOR), defined as the time from documentation of tumor response to disease progression, Progression-Free Survival (PFS), defined as the time from study enrolment until objective tumor progression or death, OS, defined as the time from study entry to death from any cause, Time to Treatment Failure (TTF), Adverse events will be monitored from the date of first administration of Elraglusib and ending 30 days after the final administration of Elraglusib using the Common Terminology Criteria for Adverse Events (CTCAE), v5.0, Correlation of disease control rate with tumor molecular profiles
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year survival rate of patients treated on the Elraglusib schedule chosen from the run-in portion of the study compared to the control arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR), defined as: Stable disease for ≥16 weeks, confirmed complete response, or confirmed partial response., Objective response rate (ORR), defined as the percent of patients with Complete Response (CR) or Partial Response (PR) according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) criteria relative to the efficacy population., Duration of Response (DOR), defined as the time from documentation of tumor response to disease progression, Progression-Free Survival (PFS), defined as the time from study enrolment until objective tumor progression or death, OS, defined as the time from study entry to death from any cause, Time to Treatment Failure (TTF), Adverse events will be monitored from the date of first administration of Elraglusib and ending 30 days after the final administration of Elraglusib using the Common Terminology Criteria for Adverse Events (CTCAE), v5.0, Correlation of disease control rate with tumor molecular profiles | — |
Countries
Belgium, France, Portugal, Spain