Patients with metastatic GIST
Conditions
Brief summary
The primary endpoint will be the Progression-Free Survival (PFS)
Detailed description
Overall survival is defined as the time from the date of randomisation until the date of death due to any cause., Objective Response Rate (ORR) is the proportion of patients with a Complete Response or Partial Response as Best Overall Response., Best Overall Response (BOR) is described as the proportion of patients with a best overall response of Complete Response., The patient's Quality of Life will be assessed using the EORTC QLQ-C30., The tolerance profile will be described mainly on the frequency of adverse events coded using the common toxicity criteria (NCI-CTC v5.0) grade.
Interventions
DRUGThis refers to placebo number: PL1 (LENVIMA)
Pharmaceutical form: Capsule
Route of administration: Oral use
Sponsors
Centre Leon Berard
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the Progression-Free Survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival is defined as the time from the date of randomisation until the date of death due to any cause., Objective Response Rate (ORR) is the proportion of patients with a Complete Response or Partial Response as Best Overall Response., Best Overall Response (BOR) is described as the proportion of patients with a best overall response of Complete Response., The patient's Quality of Life will be assessed using the EORTC QLQ-C30., The tolerance profile will be described mainly on the frequency of adverse events coded using the common toxicity criteria (NCI-CTC v5.0) grade. | — |
Countries
France
Outcome results
None listed