Suspended
A Phase I Study of Subutinib Maleate Capsules on Toleration and Pharmacokinetics
What is being tested
Subutinib Maleate capsules
Drug
Who is being recruted
From 18 to 70 Years
+25 Eligibility Criteria
How is the trial designed
Prevention Study
Phase 1
Interventional
Study Start: March 2013
Summary
Principal SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ContactCao j nin, doctor
Last updated: March 8, 2013Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.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 capsules.
Principal SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ContactCao j nin, doctor
Last updated: March 8, 2013Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
9 inclusion criteria required to participate
Aged 18 to 70 years old; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; Life expectancy greater than 3 months
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
Blood test: Hb >= 100g/L(no blood transfusion within 14 days); ANC >= 1.5x109/L, PLT >= 100x109/L
Doppler ultrasound measurement: LVEF >= LLN
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16 exclusion criteria prevent from participating
Abnormal coagulation: The subject has bleeding tendency such as active peptic ulcer or the subject is receiving thrombolytic or anticoagulant therapy
Abnormal thyroid function
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 study
Central nervous system metastasis definitely
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalDose escalation will be dependent on any dose limiting toxicities
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
Fudan University Shanghai Cancer Center
Shanghai, ChinaOpen Fudan University Shanghai Cancer Center in Google MapsSuspendedOne Study Center