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

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ClinicalTrials.gov Identifier: NCT02577458
Recruitment Status : Unknown
Verified January 2018 by AnewPharma.
Recruitment status was:  Recruiting
First Posted : October 16, 2015
Last Update Posted : January 10, 2018
Sponsor:
Collaborator:
Beijing Cancer Hospital
Information provided by (Responsible Party):
AnewPharma

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Recurrent Drug: CM082 Drug: Everolimus Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of the Combination of CM082 With Everolimus in Patients With Metastatic Renal Cell Carcinoma (RCC): Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy
Study Start Date : September 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
Experimental: CM082 plus everolimus
CM082 plus everolimus
Drug: CM082
CM082 tablets taken orally once a day on 28-day cycles
Other Name: X-82

Drug: Everolimus
Everolimus tablets taken orally once a day on 28-day cycles
Other Name: Affinitor




Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 12 months ]
    To determine the Maximum Tolerated Dose of the Combination in Chinese RCC Patients


Secondary Outcome Measures :
  1. Pharmacokinetics assessed by area under the plasma concentration versus time curve (AUC) of CM082 and everolimus [ Time Frame: 12 months ]
  2. Objective response rate [ Time Frame: 18 months ]
    Objective response rate (ORR)

  3. Progress free survival [ Time Frame: 24 months ]
    Progress free survival (PFS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 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
  • Measurable disease per Recist1.1
  • Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1
  • Life expectancy of at least 12 weeks
  • No abnormal bone marrow function
  • Adequate heart, lung, liver, kidney organ system functions, and meet the following requirements:

    • 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.
    • Creatinine ≤ 1.5 x ULN
    • Urine protein <1+
    • QTcF < 450 ms
    • LVEF ≥ 50%
  • At least 4 weeks after receiving cancer therapy (i.e., chemotherapy, radiation therapy, biologic therapy, hormonal therapy); 3 months after surgery and recovered
  • 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
  • Other tumors in addition to renal cell carcinoma
  • Have taken strong cytochrome P450 3A4 inhibitors or inducers in the last 2 weeks
  • Concomitant use of drugs with a risk of causing prolonged corrected QT interval and/or Torsades de Pointes
  • Patients with a history of intolerance to, or significant toxicity with VEGFR tyrosine kinase inhibitor(s) (TKI) or everolimus
  • Females who are pregnant or breastfeeding
  • Those in reproductive ages who refuse to use contraception
  • 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
  • Patients with known severe lung disorders such as asthma, chronic obstructive pulmonary disease (COPD)
  • Patients who are HIV positive
  • 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): NCT02577458


Contacts
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Contact: Donghua Liu, M.D 21-50790731 dhliu@anewpharma.com
Contact: Yan He, M.D 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
Beijing Cancer Hospital
Investigators
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Study Chair: Jun Guo, M.D Beijing Cancer Hospital
Principal Investigator: Xinan Sheng, M.D Beijing Cancer Hospital
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Responsible Party: AnewPharma
ClinicalTrials.gov Identifier: NCT02577458    
Other Study ID Numbers: CM082-CA-I-103
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs