NCT03095040

CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma

The Efficacy and Safety of CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma: a Randomized, Double-blind, Double Dummy, Multicenter Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: AnewPharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double blind, phase 2/3 study is aimed to evaluate the efficacy and safety of CM082 in combination with everolimus in Chinese patients with advanced renal cell carcinoma. The primary endpoint is progression-free survival.

Conditions

• Renal Cell Cancer Metastatic

Interventions

Type	Name	Description
DRUG	CM082 combined with everolimus	CM082 tablets (200 mg, 2 tablets) taken orally once a day on 28-day cycles, everolimus tablets (10 mg, 2 tablets) taken orally once a day on 28-day cycles
DRUG	CM082	CM082 tablets (200 mg, 2 tablets) taken orally once a day on 28-day cycles, dummy tablets for everolimus (2 tablets) taken orally once a day on 28-day cycles
DRUG	Everolimus	Everolimus tablets (10 mg, 2 tablets) taken orally once a day on 28-day cycles, dummy tablets for CM082 (2 tablets) taken orally once a day on 28-day cycles

Timeline

• Start date: 2016-12-16
• Primary completion: 2021-02-01
• Completion: 2021-12-01
• First posted: 2017-03-29
• Last updated: 2021-02-08

Locations

1 site across 1 country: China