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Phase I Clinical Study of Metatinib Tromethamine Tablet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02004548
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : December 29, 2015
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumors Drug: Metatinib Tromethamine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Multiple Dose Escalation Clinical Trial of Metatinib Tromethamine Tablet in Patients With Advanced or Metastatic Solid Tumors
Study Start Date : May 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Metatinib Tromethamine

Primary Outcome Measures :
  1. Dose-limiting Toxicity (DLT) [ Time Frame: up to day 32 ]
  2. Maximum Tolerated Dose (MTD) [ Time Frame: up to day 32 ]

Secondary Outcome Measures :
  1. Cmax [ Time Frame: d1、d2、d3、d8、d15、d22、d29、d30、d31 ]
  2. AUC [ Time Frame: d1、d2、d3、d8、d15、d22、d29、d30、d31 ]
  3. Objective response rate (ORR) [ Time Frame: week 4, week 10, week 16 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT02004548

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China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
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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

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Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd. Identifier: NCT02004548     History of Changes
Other Study ID Numbers: SIM-89-1
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: November 2015