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CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma | Clinical Trials | Clareo Health

UNKNOWNPHASE3

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

NCT03095040•AnewPharma

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

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

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

December 16, 2016

Primary Completion Date

February 1, 2021

Completion Date

December 1, 2021

Last Updated

February 8, 2021

Enrollment

390

ESTIMATED participants

Conditions

Renal Cell Cancer Metastatic

Interventions

CM082 combined with everolimus

DRUG

CM082

DRUG

Everolimus

DRUG

Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue

NCT06648902

Renal Cell Cancer MetastaticKidney Cancer+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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