Phase 1 Study of the Combination of CM082 With Everolimus in Patients With Metastatic Renal Cell Carcinoma (RCC): Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy

Uncategorized

Phase 1 Study of the Combination of CM082 With Everolimus in Patients With Metastatic Renal Cell Carcinoma (RCC): Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy

Condition: Renal Cell Carcinoma Recurrent

Intervention:

  • Drug: CM082
  • Drug: Everolimus

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02577458

Sponsor: AnewPharma

Primary Outcome Measures:

  • Measure: Maximum Tolerated Dose
  • Time Frame: 12 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Pharmacokinetics assessed by area under the plasma concentration versus time curve (AUC) of CM082 and everolimus
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Objective response rate
  • Time Frame: 18 months
  • Safety Issue:
  • Measure: Progress free survival
  • Time Frame: 24 months
  • Safety Issue:

Estimated Enrollment: 18

Study Start Date: September 2015

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum 70 Years
  • Gender: All

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

Contact:

  • Donghua Liu, M.D
  • 21-50790731

Location:

  • Beijing Cancer Hospital
  • Beijing Beijing 100142 China

View trial on ClinicalTrials.gov

X