NCT02724020

MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drugs being tested in this study are called MLN0128 and MLN1117. MLN0128 and MLN1117 are being tested to treat people who have mccRCC. This study will assess the efficacy and safety of MLN0128 and MLN1117 as well as how it is processed by the body in participants with advanced or mccRCC. The study will enroll approximately 96 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups: * Everolimus 10 mg once daily * MLN0128 30 mg once weekly * MLN0128 4 mg once daily for 3 days per week + MLN1117 200 mg once daily for 3 days per week All participants will be asked to take the study drug at the same time on each scheduled day. This multi-center trial will be conducted worldwide. The overall time to participate in this study is 2 years after last participant is randomized, or when the last participant discontinues study treatment (approximately 3 years). Participants will make multiple visits to the clinic including a follow-up visit 30 to 40 days after receiving their last dose of study drug or prior to start of subsequent anticancer therapy for safety assessment. Participants will then be followed for Progression Free and Overall Survival.

Conditions

• Clear-cell Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Everolimus	Everolimus capsules.
DRUG	MLN0128	MLN0128 capsules.
DRUG	MLN1117	MLN1117 capsules.

Timeline

• Start date: 2016-06-30
• Primary completion: 2020-02-03
• Completion: 2020-10-13
• First posted: 2016-03-31
• Last updated: 2021-11-19
• Results posted: 2021-02-21

Locations

36 sites across 8 countries: United States, Canada, Czechia, France, Italy, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study