Renal Cell Carcinoma Recurrent Clinical Trial
Official title:
Phase 1 Study of the Combination of CM082 With Everolimus in Patients With Metastatic Renal Cell Carcinoma (RCC): Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy
Verified date | January 2018 |
Source | AnewPharma |
Contact | Donghua Liu, M.D |
Phone | 21-50790731 |
dhliu[@]anewpharma.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 18 |
Est. completion date | June 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 - Urine protein <1+ - QTcF < 450 ms - LVEF = 50% - At least 4 weeks after receiving cancer therapy (i.e., chemotherapy, radiation therapy, biologic therapy, hormonal therapy); 3 months after surgery and recovered - 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 - 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 - Patients with known severe lung disorders such as asthma, chronic obstructive pulmonary disease (COPD) - Patients who are HIV positive - Drug or alcohol abuser |
Country | Name | City | State |
---|---|---|---|
China | Beijing Cancer Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
AnewPharma | Beijing Cancer Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose | To determine the Maximum Tolerated Dose of the Combination in Chinese RCC Patients | 12 months | |
Secondary | Pharmacokinetics assessed by area under the plasma concentration versus time curve (AUC) of CM082 and everolimus | 12 months | ||
Secondary | Objective response rate | Objective response rate (ORR) | 18 months | |
Secondary | Progress free survival | Progress free survival (PFS) | 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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