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

February 4, 2021 updated by: AnewPharma

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

390

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 ≥1.5*109/L (1500/mm3), platelet ≥100*109/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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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:
  • Affinitor
  • X-82
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 12 months
The internal between the date of randomization and the date of disease progression, unaccepted toxicity, or death
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 36 months
The internal between the date of randomization and the date of death
36 months
Objective response rate
Time Frame: 8 weeks
The percentage of patients with tumor response in overall population
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AnewPharma

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 16, 2016

Primary Completion (ANTICIPATED)

February 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

March 23, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (ACTUAL)

March 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 4, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM082-CA-Ⅱ-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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