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

AnewPharma1 site in 1 country390 target enrollmentDecember 16, 2016

ConditionsRenal Cell Cancer Metastatic

InterventionsCM082 combined with everolimus CM082 Everolimus

DrugsCM082 combined with everolimus CM082 Everolimus

Overview

Phase: Phase 3
Intervention: CM082 combined with everolimus
Conditions: Renal Cell Cancer Metastatic
Sponsor: AnewPharma
Enrollment: 390
Locations: 1
Primary Endpoint: Progression-free survival
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 16, 2016

End Date

December 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AnewPharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma
•Progressed on at least one standard therapy with VEGFR TKI
•Measurable disease per Recist v1.1
•Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1
•Life expectancy of at least 12 weeks
•Adequate organ functions, and meet the following requirements:
•Bone marrow: ANC ≥1.5\*109/L (1500/mm3), platelet ≥100\*109/L, and hemoglobin ≥9 g/dL Liver: Total bilirubin ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5x the upper limit of normal (ULN) if no liver involvement or ≤5x the upper limit of normal with liver involvement Kidney: Creatinine ≤ 1.25 x ULN, urine protein \<1+ Heart: LVEF ≥ 50%
•Willingness and ability to comply with trial and follow-up procedures
•Ability to understand the nature of this trial and give written informed consent

Exclusion Criteria

•Currently receiving anti-cancer treatment; currently or previously have received 2 or more systemic anti-cancer treatment
•Other tumors in addition to renal cell carcinoma
•Females who are pregnant or breastfeeding
•Known hypersensitivities to CM082 or everolimus
•Those with concurrent condition(e.g. psychological, neuronal, cardiovascular, respiratory conditions or infections) that in the investigator's opinion would jeopardize compliance with the protocol
•Patients with known central nervous system (CNS) metastases
•Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of CM082 or everolimus
•Any active infection
•Drug or alcohol abuser