Study of the Combination of CM082 With Everolimus in Patients With mRCC

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AnewPharma
• Collaborator: Beijing Cancer Hospital
• Treatments: Everolimus; Sirolimus

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