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

NCT03095040 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2021-02-08

No results posted yet for this study

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.

Conditions

  • Renal Cell Cancer Metastatic

Interventions

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

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

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

Sponsors & Collaborators

  • AnewPharma

    lead INDUSTRY

Principal Investigators

  • Jun Guo, MD · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-16
Primary Completion
2021-02-28
Completion
2021-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03095040 on ClinicalTrials.gov