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Vorolanib

Protein Kinase Inhibitors

Enzyme Inhibitors

CM082 tablets taken orally 200、400、600 and 800 mg (QD or BID)

CM082

Jin Li, M.D

This is a Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Oral Dosing of CM082 tablets in Chinese Patients With Advanced Malignant Solid Tumors

This is a single-center、open-label and non-controlled Phase 1 study which will be conducted in two parts: part A is the dose-escalation phase; part B is dose-expansion phase. The dose-escalation phase is guided by pharmacokinetics (PK) and safety, according to the standard 3+3 dose-escalation schema. CM082 tablets are taken orally with a starting dose of 200 mg and a subsequent dose of 400, 600 and 800 mg. The way of administration is as follows: QD or BID. The primary objective of this study is to determine the maximum tolerable dose (MTD)、characteristics of dose-limited toxicity (DLT) and pharmacokinetics (PK). Secondary objectives include safety、tolerability and preliminary efficacy

The initial dose is set at 200 mg, followed by 400 mg, 600 mg and 800 mg for dose increment.

Study of Challenge Meditech 082 (CM082) Tablets in Patients With Advanced Malignant Solid Tumors

Phase I Study of CM082 Tablets in the Treatment of Advanced Malignant Solid Tumors: Safety, Tolerance and Pharmacokinetics

Characteristics of dose-limiting toxicity (DLT), evaluation criteria: National Cancer Institute (NCI) CTC classification (version 4.03)

Area under the time curve of blood concentration from 0 h to the last time of blood collection

0 to Infinite Area under Blood Drug Concentration Curve

Shanghai East Hospital

AnewPharma

Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Recurrence

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

Anti-Infective Agents

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Immunosuppressive Agents

Immunologic Factors

CM082 tablets taken orally once a day on 28-day cycles

Everolimus tablets taken orally once a day on 28-day cycles

Donghua Liu, M.D

Yan He, M.D

Xinan Sheng, M.D

Jun Guo, M.D

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CM082 in Combination with Everolimus in Chinese Patients With Advanced Renal Cell Carcinoma.

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CM082 in Combination with Everolimus in Chinese Patients With Renal Cell Carcinoma (RCC). After the maximum tolerated dose (MTD) or the optimal biological dose is identified, an expansion cohort of \~10 advanced renal cell carcinoma patients will be enrolled to further characterize the safety and tumor response by CT.

Study of the Combination of CM082 With Everolimus in Patients With mRCC

Phase 1 Study of the Combination of CM082 With Everolimus in Patients With Metastatic Renal Cell Carcinoma (RCC): Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy

To determine the Maximum Tolerated Dose of the Combination in Chinese RCC Patients

Peking University Cancer Hospital & Institute

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 combined with everolimus

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 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

Jun Guo, MD

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.

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

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

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

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

The percentage of patients with tumor response in overall population

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Challenge Meditech 082 (CM082) Tablets in Patients With Advanced Malignant Solid Tumors	NCT03792958	Advanced Malign...	CM082	18 Years -	AnewPharma
Study of the Combination of CM082 With Everolimus in Patients With mRCC	NCT02577458	Renal Cell Carc...	CM082 Everolimus	18 Years - 70 Years	AnewPharma
CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma	NCT03095040	Renal Cell Canc...	CM082 combined ... CM082 Everolimus	18 Years - 75 Years	AnewPharma
Study of the Combination of CM082 With Everolimus in Patients With mRCC	NCT02577458	Renal Cell Carc...	CM082 Everolimus	18 Years - 70 Years	AnewPharma
CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma	NCT03095040	Renal Cell Canc...	CM082 combined ... CM082 Everolimus	18 Years - 75 Years	AnewPharma
Study of Challenge Meditech 082 (CM082) Tablets in Patients With Advanced Malignant Solid Tumors	NCT03792958	Advanced Malign...	CM082	18 Years -	AnewPharma
CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma	NCT03095040	Renal Cell Canc...	CM082 combined ... CM082 Everolimus	18 Years - 75 Years	AnewPharma

Spots Global Cancer Trial Database for cm082

Every month we try and update this database with for cm082 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cm082

Every month we try and update this database with for cm082 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cm082 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.