Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT02577458
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
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02577458
Study Brief:
Protocol Section:
NCT02577458