Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02724020 | MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma | PHASE2 | COMPLETED | 96 | — | — | Jun 30, 2016 | Oct 13, 2020 | Nov 19, 2021 | 36 | United States, Canada +6 |
PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
| Arm | Type | Description |
|---|---|---|
| Arm A: Single-agent Everolimus 10 mg QD | ACTIVE_COMPARATOR | Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study). |
| Arm B: Single-agent MLN0128 30 mg QW | EXPERIMENTAL | MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study). |
| Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD | EXPERIMENTAL | MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.43 weeks up to end of study). |
| Name | Type | Description |
|---|---|---|
| Everolimus | DRUG | Everolimus capsules. |
| MLN0128 | DRUG | MLN0128 capsules. |
| MLN1117 | DRUG | MLN1117 capsules. |
Inclusion Criteria: 1. Male or female participants aged 18 years or older. 2. Histologically confirmed renal cell carcinoma (RCC) with a clear-cell component. 3. Evidence that the RCC is advanced or metastatic. 4. Radiologic evidence of PD (according to RECIST Version 1.1) either during or within 6...