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

NCT ID: NCT03095040

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-16
• Study Completion Date: 2021-12-31

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.

Conditions

Renal Cell Cancer Metastatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CM082 combined with everolimus

Group Type: EXPERIMENTAL

CM082 combined with everolimus

Intervention Type: DRUG

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

CM082

Group Type: EXPERIMENTAL

CM082

Intervention Type: DRUG

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

Everolimus

Group Type: ACTIVE_COMPARATOR

Everolimus

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

X-82; Affinitor; X-82; Affinitor

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AnewPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Guo, MD

Role: STUDY_CHAIR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Sheng X, Ye D, Zhou A, Yao X, Luo H, He Z, Wang Z, Zhao Y, Ji Z, Zou Q, He C, Guo J, Tu X, Liu Z, Shi B, Liu B, Chen P, Wei Q, Hu Z, Zhang Y, Jiang K, Zhou F, Wu D, Fu C, Li X, Wu B, Wang L, Qin S, Li G, Liu Y, Guo H, Chen K, Zhang D, Wang G, Ding L, Wang Y, Yuan X, Guo J. Efficacy and safety of vorolanib plus everolimus in metastatic renal cell carcinoma: A three-arm, randomised, double-blind, multicentre phase III study (CONCEPT). Eur J Cancer. 2023 Jan;178:205-215. doi: 10.1016/j.ejca.2022.10.025. Epub 2022 Nov 1.

Reference Type: DERIVED

PMID: 36459768 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32335374 (View on PubMed)

Other Identifiers

CM082-CA-Ⅱ-201

Identifier Type: -

Identifier Source: org_study_id