CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 96 enrolled
Drug / intervention
Everolimus +2 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Histologically confirmed renal cell carcinoma with clear-cell component, advanced or metastatic
  • ✓Radiologic progression (RECIST 1.1) during or within 6 months after stopping most recent systemic RCC therapy
  • ✓At least 1 prior line of VEGF-targeted therapy, but not more than 4 total prior systemic therapy lines
  • ✓Karnofsky Performance Status ≥70%
Key exclusion· 9
  • ✕CNS metastases
  • ✕Prior therapy with PI3K, AKT, or mTOR inhibitors
  • ✕Known hypersensitivity to everolimus or rapamycin derivatives
  • ✕Malabsorption disorders or GI conditions affecting drug absorption; enteric stomata

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02724020
NCT02724020Phase 2Completed
CompareCT.gov

A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Single-Agent MLN0128 and the Combination of MLN0128+MLN1117 Compared With Everolimus in the Treatment of Adult Patients With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma That Has Progressed on Vascular Endothelial Growth Factor-Targeted Therapy

Millennium Pharmaceuticals, Inc.·interventional·Posted Mar 31, 2016·Updated Nov 19, 2021

In Brief

A Phase 2 clinical trial evaluating Everolimus, MLN0128, and 1 other intervention for Clear-cell Metastatic Renal Cell Carcinoma. Completed, enrolled 96 participants across 36 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClear-cell Metastatic Renal Cell Carcinoma
CountriesCanada, Czechia, France, Italy, Poland, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 31, 2016
Enrollment StartJun 30, 2016
Primary CompletionFeb 3, 2020
Study CompletionOct 13, 2020
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.3 years ago

Interventions

Everolimusdrug

Everolimus capsules.

MLN0128drug

MLN0128 capsules.

MLN1117drug

MLN1117 capsules.