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

AnewPharma

Status and phase

Unknown

Phase 3

Conditions

Renal Cell Cancer Metastatic

Treatments

Drug: CM082 combined with everolimus

Drug: Everolimus

Drug: CM082

Study type

Interventional

Funder types

Industry

Identifiers

NCT03095040

CM082-CA-Ⅱ-201

Details and patient eligibility

About

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.

Enrollment

390 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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