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

Primary Purpose

Renal Cell Carcinoma Recurrent

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CM082
Everolimus
Sponsored by
AnewPharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma Recurrent

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CM082 plus everolimus

Arm Description

CM082 plus everolimus

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose
To determine the Maximum Tolerated Dose of the Combination in Chinese RCC Patients

Secondary Outcome Measures

Pharmacokinetics assessed by area under the plasma concentration versus time curve (AUC) of CM082 and everolimus
Objective response rate
Objective response rate (ORR)
Progress free survival
Progress free survival (PFS)

Full Information

First Posted
October 12, 2015
Last Updated
January 8, 2018
Sponsor
AnewPharma
Collaborators
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02577458
Brief Title
Study of the Combination of CM082 With Everolimus in Patients With mRCC
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AnewPharma
Collaborators
Peking University Cancer Hospital & Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma Recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CM082 plus everolimus
Arm Type
Experimental
Arm Description
CM082 plus everolimus
Intervention Type
Drug
Intervention Name(s)
CM082
Other Intervention Name(s)
X-82
Intervention Description
CM082 tablets taken orally once a day on 28-day cycles
Intervention Type
Drug
Intervention Name(s)
Everolimus
Other Intervention Name(s)
Affinitor
Intervention Description
Everolimus tablets taken orally once a day on 28-day cycles
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose
Description
To determine the Maximum Tolerated Dose of the Combination in Chinese RCC Patients
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pharmacokinetics assessed by area under the plasma concentration versus time curve (AUC) of CM082 and everolimus
Time Frame
12 months
Title
Objective response rate
Description
Objective response rate (ORR)
Time Frame
18 months
Title
Progress free survival
Description
Progress free survival (PFS)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donghua Liu, M.D
Phone
21-50790731
Email
dhliu@anewpharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yan He, M.D
Phone
18280417935
Email
yhe@anewpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Guo, M.D
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xinan Sheng, M.D
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinan Sheng, M.D
Phone
010-88196951
Email
doctor_sheng@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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