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

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ClinicalTrials.gov Identifier: NCT03095040
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
AnewPharma

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.

Condition or disease Intervention/treatment Phase
Renal Cell Cancer Metastatic Drug: CM082 combined with everolimus Drug: CM082 Drug: Everolimus Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CM082 combined with everolimus Drug: 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
Other Names:
  • X-82
  • Affinitor

Experimental: CM082 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
Other Name: X-82

Active Comparator: Everolimus 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
Other Name: Affinitor




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 12 months ]
    The internal between the date of randomization and the date of disease progression, unaccepted toxicity, or death


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 36 months ]
    The internal between the date of randomization and the date of death

  2. Objective response rate [ Time Frame: 8 weeks ]
    The percentage of patients with tumor response in overall population



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095040


Contacts
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Contact: Donghua Liu, MD 86-21-50790731 dhliu@anewpharma.com
Contact: Yan He, MD 18280417935 yhe@anewpharma.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Xinan Sheng, M.D    010-88196951    doctor_sheng@126.com   
Sponsors and Collaborators
AnewPharma
Investigators
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Study Chair: Jun Guo, MD Beijing Cancer Hospital

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Responsible Party: AnewPharma
ClinicalTrials.gov Identifier: NCT03095040     History of Changes
Other Study ID Numbers: CM082-CA-Ⅱ-201
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents