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

Primary Purpose

Renal Cell Cancer Metastatic

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

CM082 combined with everolimus

CM082

Everolimus

About this trial

This is an interventional treatment trial for Renal Cell Cancer Metastatic

Eligibility Criteria

18 Years - 75 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 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

Sites / Locations

Beijing Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

CM082 combined with everolimus

CM082

Everolimus

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival

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

Secondary Outcome Measures

Overall survival

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

Objective response rate

The percentage of patients with tumor response in overall population

Full Information

NCT ID

NCT03095040

First Posted

March 23, 2017

Last Updated

February 4, 2021

Sponsor

AnewPharma

1. Study Identification

Unique Protocol Identification Number

NCT03095040

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 16, 2016 (Actual)

Primary Completion Date

February 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AnewPharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Cancer Metastatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CM082 combined with everolimus

Arm Type

Experimental

Arm Title

CM082

Arm Type

Experimental

Arm Title

Everolimus

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

CM082 combined with everolimus

Other Intervention Name(s)

X-82, Affinitor

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

CM082

Other Intervention Name(s)

X-82

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Everolimus

Other Intervention Name(s)

Affinitor

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free survival

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Overall survival

Description

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

Time Frame

36 months

Title

Objective response rate

Description

The percentage of patients with tumor response in overall population

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Guo, MD

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Study Chair

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32335374

Citation

Sheng X, Yan X, Chi Z, Cui C, Si L, Tang B, Li S, Mao L, Lian B, Wang X, Bai X, Zhou L, Kong Y, Dai J, Ding L, Mao L, Guo J. Phase 1 trial of vorolanib (CM082) in combination with everolimus in patients with advanced clear-cell renal cell carcinoma. EBioMedicine. 2020 May;55:102755. doi: 10.1016/j.ebiom.2020.102755. Epub 2020 Apr 23.

Results Reference

derived

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

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