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

Renal Cell Cancer Metastatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03095040
• Other study ID #: CM082-CA-?-201
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 16, 2016
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: AnewPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 390
• Est. completion date: December 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Cancer Metastatic

Intervention

Drug:
• CM082 combined with everolimus
CM082 tablets (200 mg, 2 tablets) taken orally once a day on 28-day cycles, everolimus tablets (10 mg, 2 tablets) taken orally once a day on 28-day cycles
• CM082
CM082 tablets (200 mg, 2 tablets) taken orally once a day on 28-day cycles, dummy tablets for everolimus (2 tablets) taken orally once a day on 28-day cycles
• Everolimus
Everolimus tablets (10 mg, 2 tablets) taken orally once a day on 28-day cycles, dummy tablets for CM082 (2 tablets) taken orally once a day on 28-day cycles

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
AnewPharma

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	The internal between the date of randomization and the date of disease progression, unaccepted toxicity, or death	12 months
Secondary	Overall survival	The internal between the date of randomization and the date of death	36 months
Secondary	Objective response rate	The percentage of patients with tumor response in overall population	8 weeks