Phase 1 Study of the Combination of CM082 With Everolimus in Patients With Metastatic Renal Cell Carcinoma (RCC): Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy
Overview
- Phase
- Phase 1
- Intervention
- CM082
- Conditions
- Renal Cell Carcinoma Recurrent
- Sponsor
- AnewPharma
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Maximum Tolerated Dose
- Last Updated
- 8 years ago
Overview
Brief Summary
This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CM082 in Combination with Everolimus in Chinese Patients With Advanced Renal Cell Carcinoma.
Detailed Description
This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CM082 in Combination with Everolimus in Chinese Patients With Renal Cell Carcinoma (RCC). After the maximum tolerated dose (MTD) or the optimal biological dose is identified, an expansion cohort of \~10 advanced renal cell carcinoma patients will be enrolled to further characterize the safety and tumor response by CT.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma
- •Progressed on at least one standard therapy
- •Measurable disease per Recist1.1
- •Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1
- •Life expectancy of at least 12 weeks
- •No abnormal bone marrow function
- •Adequate heart, lung, liver, kidney organ system functions, and meet the following requirements:
- •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.
- •Creatinine ≤ 1.5 x ULN
Exclusion Criteria
- •Currently receiving anti-cancer treatment
- •Other tumors in addition to renal cell carcinoma
- •Have taken strong cytochrome P450 3A4 inhibitors or inducers in the last 2 weeks
- •Concomitant use of drugs with a risk of causing prolonged corrected QT interval and/or Torsades de Pointes
- •Patients with a history of intolerance to, or significant toxicity with VEGFR tyrosine kinase inhibitor(s) (TKI) or everolimus
- •Females who are pregnant or breastfeeding
- •Those in reproductive ages who refuse to use contraception
- •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
Arms & Interventions
CM082 plus everolimus
CM082 plus everolimus
Intervention: CM082
CM082 plus everolimus
CM082 plus everolimus
Intervention: Everolimus
Outcomes
Primary Outcomes
Maximum Tolerated Dose
Time Frame: 12 months
To determine the Maximum Tolerated Dose of the Combination in Chinese RCC Patients
Secondary Outcomes
- Pharmacokinetics assessed by area under the plasma concentration versus time curve (AUC) of CM082 and everolimus(12 months)
- Objective response rate(18 months)
- Progress free survival(24 months)