NCT02577458

Study of the Combination of CM082 With Everolimus in Patients With mRCC

Phase 1 Study of the Combination of CM082 With Everolimus in Patients With Metastatic Renal Cell Carcinoma (RCC): Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: AnewPharma · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CM082 in Combination with Everolimus in Chinese Patients With Advanced Renal Cell Carcinoma.

Detailed description

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CM082 in Combination with Everolimus in Chinese Patients With Renal Cell Carcinoma (RCC). After the maximum tolerated dose (MTD) or the optimal biological dose is identified, an expansion cohort of \~10 advanced renal cell carcinoma patients will be enrolled to further characterize the safety and tumor response by CT.

Conditions

• Renal Cell Carcinoma Recurrent

Interventions

Type	Name	Description
DRUG	CM082	CM082 tablets taken orally once a day on 28-day cycles
DRUG	Everolimus	Everolimus tablets taken orally once a day on 28-day cycles

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-03-01
• Completion: 2018-06-01
• First posted: 2015-10-16
• Last updated: 2018-01-10

Locations

1 site across 1 country: China