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

Conditions

Renal Cell Cancer Metastatic

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.

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.

2022-11-0113 citations

10.1016/j.ejca.2022.10.025

Vorolanib, everolimus, and the combination in patients with pretreated metastatic renal cell carcinoma (CONCEPT study): A randomized, phase 3, double-blind, multicenter trial.

Xinan Sheng, Dingwei Ye, Aiping Zhou, Xin Yao, Hong Luo et al. (20 authors)

Journal of Clinical Oncology2021-05-201 citations

10.1200/jco.2021.39.15_suppl.4512

Phase 1 trial of vorolanib (CM082) in combination with everolimus in patients with advanced clear-cell renal cell carcinoma.

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.

2020-04-239 citations

10.1016/j.ebiom.2020.102755

Vorolanib (CM082), everolimus, and the combination in patients with pretreated metastatic renal cell carcinoma (CONCEPT study): A randomized, phase 2/3, double-blind, multi-center trial.

Jun Guo, Xinan Sheng, Dingwei Ye, Zhisong He, Aiping Zhou et al. (20 authors)

Journal of Clinical Oncology2018-05-20

10.1200/jco.2018.36.15_suppl.tps4605

Interventions

DRUGCM082 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

DRUGCM082

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

DRUGEverolimus

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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 ≥1.5\*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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed