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

Phase 3

• Conditions: Renal Cell Cancer Metastatic
• Interventions: Drug: CM082 combined with everolimus; Drug: CM082; Drug: Everolimus

• Registration Number: NCT03095040
• Lead Sponsor: AnewPharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-16
• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-29
• Status Verified: 2021-02
• Primary Completion: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-08
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 390

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CM082 combined with everolimus	CM082 combined with everolimus	-
CM082	CM082	-
Everolimus	Everolimus	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival	12 months	The internal between the date of randomization and the date of disease progression, unaccepted toxicity, or death

Secondary Outcome Measures

Name	Time	Method
Overall survival	36 months	The internal between the date of randomization and the date of death
Objective response rate	8 weeks	The percentage of patients with tumor response in overall population

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China