NCT03095040UnknownPhase 3
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 enrollmentStarted: December 16, 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 390
- Locations
- 1
- Primary Endpoint
- Progression-free survival
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CM082 combined with everolimus
Experimental
Intervention: CM082 combined with everolimus (Drug)
CM082
Experimental
Intervention: CM082 (Drug)
Everolimus
Active Comparator
Intervention: Everolimus (Drug)
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 12 months
The internal between the date of randomization and the date of disease progression, unaccepted toxicity, or death
Secondary Outcomes
- Overall survival(36 months)
- Objective response rate(8 weeks)
Investigators
Study Sites (1)
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