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A Phase I Study of Subutinib Maleate Capsules on Toleration and Pharmacokinetics

Phase 1
18 Years
70 Years
Open (Enrolling)
Solid Tumor

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Trial Information

A Phase I Study of Subutinib Maleate Capsules on Toleration and Pharmacokinetics

The primary objective of this study is to explore the maximum tolerated dose, dose-limiting
toxicity of oral Subutinib Maleate capsules and rational dosage regimen for phase Ⅱ study,
to investigate the pharmacokinetics of single and multiple oral doses of Subutinib Maleate

Inclusion Criteria:

- Subjects who have histologically or cytologically confirmed solid tumors

- Subjects who have failed standard effective therapy or have a diagnosis for which no
standard effective treatment is available;

- Aged 18 to 70 years old; Eastern Cooperative Oncology Group (ECOG) performance status
(PS) 0-2; Life expectancy greater than 3 months;

- If the subject has been given other chemotherapy drugs, it's necessary to
discontinue them more than 4 weeks. If the chemotherapy drugs are Nitrosoureas and
Mitomycin C, it's necessary to discontinue them more than 6 weeks. If the subject has
accepted major surgery, it's necessary to wait more than 4 weeks before the subject
participating in this study.

- Blood test: Hb≥100g/L(no blood transfusion within 14 days);
ANC≥1.5×109/L, PLT≥100×109/L

- Biochemistry: TBIL and ALT and AST and Cr are in normal range, or creatinine
clearance ≥60ml/min; Triglyceride≤3.0mmol/L; Cholesterol ≤7.75mmol/L.

- Doppler ultrasound measurement: LVEF ≥ LLN

- Female subjects should agree to take contraceptives during the study and within 6
months after the study (such as intrauterine device [IUD], contraceptive drugs or
condoms); within 7 days before they enter the study, their serum or human chorionic
gonadotropin should be negative, and must be in the non-lactation period; male
subjects should agree to take contraceptives during the study and within 6 months
after the study.

- The subject is willing to participate in this study, and he/she has signed the
Informed Consent Form, with good compliance.

Exclusion Criteria:

- The subject has participated in other drug clinical research in the past 4 weeks.

- The subject is accompanied with several factors which will influence the
investigational drug administration orally, such as inability to swallow or after
gastrointestinal resection or chronic diarrhea or intestinal obstruction.

- Central nervous system metastasis definitely.

- The subject is suffering from hypertension or myocardial ischemia or myocardial
infarction or arrhythmia (including QT interval≥440ms) or Grade I heart failure.

- If the subject's systolic BP is over 140mmhg, with diastolic BP over 90mmhg, or the
subject's blood pressure is well-controlled, he/she is not permitted to enroll in
this study as well.

- The subject's urinalysis displays that urinary protein ≥ ++ , combined with 24-hour
urinary protein > 1.0g.

- The subject's is suffering from wounds or fractures which can not be cured for long

- Abnormal coagulation: The subject has bleeding tendency such as active peptic ulcer
or the subject is receiving thrombolytic or anticoagulant therapy.

- There are pre-dosing arterial/venous thrombotic events on this subject, such as
cerebrovascular accident (including TIA) or deep vein thrombosis or pulmonary

- The subject is accepting anticoagulants or vitamin K antagonists such as warfarin or
heparin or analogue therapy; If the subject's INR ≤ 1.5, he/she is allowed to use
small doses of warfarin (1mg oral q d) or small doses of aspirin(less than 100mg each
day), and the purpose of the treatment should be prevention.

- Abnormal thyroid function.

- There is history of mental drug abuse occurred in the subject, or the subject is
suffering from mental disorders.

- There is history of immunodeficiency occurred in the subject, including HIV positive
or other acquired or congenital immunodeficiency diseases, or the subject has
accepted organ transplant before.

- Lung squamous cell carcinoma.

- The subject has received small molecule targeted drug therapy of inhibition of

- According to the investigator's judgment, there are concomitant diseases which will
seriously do harm to the subject's safety or obstruct the subject to complete the

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Dose-limiting toxicity, maximum tolerated dose.

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

Li jin, doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

September 2014

Related Keywords:

  • Solid Tumor