MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma
Summary
The purpose of this study is to evaluate the efficacy and safety of single-agent MLN0128 and the combination of MLN0128 + MLN1117 compared with everolimus in the treatment of participants with metastatic clear-cell renal cell carcinoma (mccRCC) that have progressed on vascular endothelial growth factor (VEGF)-targeted therapy.
Timeline
- Start
- 2016-06-30
- Primary completion
- 2020-02-03
- Completion
- 2020-10-13
Outcome
Missed primary endpoint
registry analysis (superiority test); Arm A: Single-agent Everolimus 10 mg QD vs Arm B: Single-agent MLN0128 30 mg QW; p =0.388; Hazard Ratio (HR) 1.33 (95% CI 0.75 to 2.36) NCT02724020 ↗
registry analysis (superiority test); Arm A: Single-agent Everolimus 10 mg QD vs Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD; p = 0.667; Hazard Ratio (HR) 1.37 (95% CI 0.75 to 2.52) NCT02724020 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Everolimus | Small molecule | 10 mg | Oral |
| Subject | Sapanisertib | Small molecule | 4 mg | Oral |
| Subject | Sapanisertib | Small molecule | 30 mg | Oral |
| Subject | Serabelisib | Small molecule | 200 mg | Oral |