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Phase I Clinical Study of Metatinib Tromethamine Tablet

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ClinicalTrials.gov Identifier: NCT02004548
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 26, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date December 29, 2015
Study Start Date  ICMJE May 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
  • Dose-limiting Toxicity (DLT) [ Time Frame: up to day 32 ]
  • Maximum Tolerated Dose (MTD) [ Time Frame: up to day 32 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02004548 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
  • Cmax [ Time Frame: d1、d2、d3、d8、d15、d22、d29、d30、d31 ]
  • AUC [ Time Frame: d1、d2、d3、d8、d15、d22、d29、d30、d31 ]
  • Objective response rate (ORR) [ Time Frame: week 4, week 10, week 16 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Clinical Study of Metatinib Tromethamine Tablet
Official Title  ICMJE A Phase I, Multiple Dose Escalation Clinical Trial of Metatinib Tromethamine Tablet in Patients With Advanced or Metastatic Solid Tumors
Brief Summary

Primary Objective: To evaluate the safety, tolerability and maximum tolerated dose (MTD) of daily oral administration of metatinib tromethamine in subjects with solid tumors; Investigate the influence of food on pharmacokinetic parameters.

Secondary Objective: To evaluate the plasma pharmacokinetics (PK) of daily oral administration of metatinib tromethamine in subjects with solid tumors; To observe preliminary anti-tumor efficacy; To evaluate potential pharmacodynamic and predictive biomarkers at MTD.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced or Metastatic Solid Tumors
Intervention  ICMJE Drug: Metatinib Tromethamine
Study Arms  ICMJE Experimental: Metatinib Tromethamine
Dose escalation is in accordance with the traditional "3 +3" design, and dose groups are subsequently set as: 25, 50, 100, 200, 300, 450, 600, 800 mg/d.
Intervention: Drug: Metatinib Tromethamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2015)
18
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2013)
49
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Weight: male weight ≥ 45 kg; female weight ≥ 40 kg, body mass index (BMI) between 18~24 kg/m^2, including the boundary values;
  • The subject has a histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival;
  • Not treated with standard therapeutical regime currently, or has progressed or relapsed after standard treatment;
  • Time from last cytotoxic chemotherapy (including investigational cytotoxic agents) or biologic agents (immune modulators, cytokines) ≥ 4 weeks, or nitrosoureas or mitomycin C ≥ 6 weeks. If having received an antibody anti-tumor biological product, at least 8-week washout period is required;
  • At least 4 weeks after surgery, and the wound must be healed completely;
  • If subject has chemotherapy-induced toxicity, the adverse events must be recovered to ≤ grade 1 (NCI-CTC version 4.0) except for alopecia;
  • ECOG performance status of 0-2;
  • Expected survival time is more than three months;
  • The subject has organ and marrow function as follows:

    1. absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L,
    2. platelets ≥ 80 x 10^9/L,
    3. hemoglobin ≥ 90 g/L (blood transfusion is allowed),
    4. total bilirubin ≤ 2 x ULN (<3 x ULN with liver metastases),
    5. serum creatinine ≤ 150 μmol/L or calculated creatinine clearance ≥ 60 mL/min,
    6. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (<5 x ULN with liver metastases),
    7. uric acid <500 μmol/L,
    8. proteinuria ≤ 2 + or ≤ 2g / 24h;
  • The subject is capable of understanding and complying with the protocol and has signed the informed consent document;

Exclusion Criteria:

  • The subject is known to be positive for the human immunodeficiency virus (HIV);
  • The subject is known to be positive for hepatitis B surface antigen or hepatitis C;
  • Previous participation in other clinical trials within three months before study;
  • Concomitant chemotherapy, hormone therapy, immunotherapy program or radiotherapy;
  • The subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia;
  • The subject has psychiatric illness/social situations that would limit compliance with study requirements;
  • The subject has brain metastases;
  • Imaging study showed involvement of major blood vessels or nerves by tumor;
  • Uncontrollable hypertension (referring to systolic blood pressure> 150 mmHg and / or diastolic blood pressure> 100 mmHg after treatment) or LVEF <50%;
  • Patient with disease history of bleeding or thromboembolic events occurred within the past six months and need for preventive anticoagulant therapy;
  • Patient needs surgery within 28 days, or is expected to require surgery within 28 days after the last dose administration;
  • Significant abnormality in the important organs, such as heart, lung, liver, kidney;
  • Has third lacunar effusion with difficulty to control;
  • The subject is pregnant or breastfeeding;
  • Sexually active subjects (male and female) refuse to use medically acceptable methods of contraception during the course of the study and for 1 month following discontinuation of study drug.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02004548
Other Study ID Numbers  ICMJE SIM-89-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiangsu Simcere Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Feng Bi, MD West China Hospital
Principal Investigator: Maozhi Liang, MD West China Hospital
Principal Investigator: You Lu, MD West China Hospital
Principal Investigator: Qin Yu, MD West China Hospital
Principal Investigator: Li Zheng, MD West China Hospital
PRS Account Jiangsu Simcere Pharmaceutical Co., Ltd.
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP