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CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma

Sponsor
AnewPharma (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03095040
Collaborator
(none)
390
Enrollment
1
Location
3
Arms
59.5
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized, double blind, phase 2/3 study is aimed to evaluate the efficacy and safety of CM082 in combination with everolimus in Chinese patients with advanced renal cell carcinoma. The primary endpoint is progression-free survival.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
390 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
The Efficacy and Safety of CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma: a Randomized, Double-blind, Double Dummy, Multicenter Study
Actual Study Start Date :
Dec 16, 2016
Anticipated Primary Completion Date :
Feb 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: CM082 combined with everolimus

Drug: CM082 combined with everolimus
CM082 tablets (200 mg, 2 tablets) taken orally once a day on 28-day cycles, everolimus tablets (10 mg, 2 tablets) taken orally once a day on 28-day cycles
Other Names:
  • X-82
  • Affinitor

    		•
    Experimental: CM082

    Drug: CM082
    CM082 tablets (200 mg, 2 tablets) taken orally once a day on 28-day cycles, dummy tablets for everolimus (2 tablets) taken orally once a day on 28-day cycles
    Other Names:
  • X-82

    		•
    Active Comparator: Everolimus

    Drug: Everolimus
    Everolimus tablets (10 mg, 2 tablets) taken orally once a day on 28-day cycles, dummy tablets for CM082 (2 tablets) taken orally once a day on 28-day cycles
    Other Names:
  • Affinitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [12 months]

      The internal between the date of randomization and the date of disease progression, unaccepted toxicity, or death

    Secondary Outcome Measures

    1. Overall survival [36 months]

      The internal between the date of randomization and the date of death

    2. Objective response rate [8 weeks]

      The percentage of patients with tumor response in overall population

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma

    • Progressed on at least one standard therapy with VEGFR TKI

    • Measurable disease per Recist v1.1

    • Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1

    • Life expectancy of at least 12 weeks

    • Adequate organ functions, and meet the following requirements:

    Bone marrow: ANC ≥1.5109/L (1500/mm3), platelet ≥100109/L, and hemoglobin ≥9 g/dL Liver:

    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 Kidney: Creatinine ≤ 1.25 x ULN, urine protein <1+ Heart: LVEF ≥ 50%

    • 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; currently or previously have received 2 or more systemic anti-cancer treatment

    • Other tumors in addition to renal cell carcinoma

    • Females who are pregnant or breastfeeding

    • Known hypersensitivities to CM082 or everolimus

    • 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

    • Any active infection

    • Drug or alcohol abuser

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Cancer Hospital Beijing Beijing China 100142

    Sponsors and Collaborators

    • AnewPharma

    Investigators

    • Study Chair: Jun Guo, MD, Peking University Cancer Hospital & Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AnewPharma
    ClinicalTrials.gov Identifier:
    NCT03095040
    Other Study ID Numbers:
    • CM082-CA-Ⅱ-201
    First Posted:
    Mar 29, 2017
    Last Update Posted:
    Feb 8, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Renal Cell
    Everolimus
    Vorolanib

    Study Results

    No Results Posted as of Feb 8, 2021