Completed
ALTNA Phase I Study of Anlotinib on Tolerance and Pharmacokinetics
What is being tested
anlotinib
Drug
Who is being recruted
From 18 to 65 Years
+22 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: May 2011
Summary
Principal SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
Last updated: October 28, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2011
Actual date on which the first participant was enrolled.The primary objective of this trial is to explore the maximum tolerated dose(MTD), dose-limiting toxicity(DLT) of ALTN and rational dosage regimen for phase II study, to investigate the pharmacokinetics with single and multiple doses of ALTN from 5mg/d,10mg/d,16mg/d,12mg.
Principal SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
Last updated: October 28, 2015
Sourced 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
35 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
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 65 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
7 inclusion criteria required to participate
18-65years, ECOG:0-1,Expected survival period > 3 months
Female should be agreed to use contraceptive during the study and after 6 months (such as intrauterine device(IUD), the pill or a condom); The serum or urine pregnancy test negative before take ALTN, and is out of non-lactation period. Male should be agreed to use contraceptive during the study and after the period of 6 months
HB >= 90g/L,ANC(Absolute Neutrophil Count) >= 1.5x109/L;PLT >= 100x109/L ,BIL/ALT/AST(aspartate aminotransferase )/Cr in normal range,or CCR >= 60ml/min,TG <= 3.0mmol/L,cholesterol <= 7.75mmol/L; LVEF >= LLN
Volunteer, informed consent form (ICF) signed, compliance
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15 exclusion criteria prevent from participating
According to the researcher's judgment,there are concomitant diseases which will seriously endanger the patients or obstruct the patients to complete the clinical trial
Already diagnosed with brain metastases, spinal cord compression, cancerous meningitis, or screening CT or MRI findings of the brain or soft meningeal disease patient
Coagulant function abnormality: subject with bleeding tendency (such as active peptic ulcer) or are receiving thrombolysis or anticoagulant therapy
Has influence of oral drugs(such as unable to swallow, gastrointestinal tract after resection)
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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
Experimentaldosage form:capsule dosage:5mg,10mg,16mg,12mg frequency:once one day duration:Continuous two weeks then stop a week
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
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, ChinaOpen Cancer Institute and Hospital, Chinese Academy of Medical Sciences in Google MapsCompletedOne Study Center