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

NCT03095040 | Unknown Phase 3

• 1 other identifier: CM082-CA-Ⅱ-201
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

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

  12 months

Secondary Outcomes (2)

• Overall survival

  36 months

• Objective response rate

  8 weeks

Study Arms (3)

CM082 combined with everolimus

EXPERIMENTAL

Drug: CM082 combined with everolimus

CM082

EXPERIMENTAL

Drug: CM082

Everolimus

ACTIVE COMPARATOR

Drug: Everolimus

Interventions

CM082 combined with everolimus 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

Also known as: X-82, Affinitor

CM082 combined with everolimus

CM082 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

Also known as: X-82

CM082

Everolimus 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

Also known as: Affinitor

Everolimus

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AnewPharma: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (2)

• 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.

  PMID: 36459768 DERIVED

• 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.

  PMID: 32335374 DERIVED

MeSH Terms

Interventions

Everolimus; vorolanib

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Jun Guo, MD

  Peking University Cancer Hospital & Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 29, 2017
• Study Start: December 16, 2016
• Primary Completion: February 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)