Advanced CancerPhase 1ALTNNCT01833923
A Phase I Study of Anlotinib on Tolerance and Pharmacokinetics
A Phase 1 study testing anlotinib in people with Advanced Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- anlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Oct 2015
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- late malignant tumor patients diagnosed with the pathological and/or cytological;
- lack of the standard treatment or treatment failure;
- 18-65years, ECOG:0-1,Expected survival period >3 months;
- stop medicine > 30 days if any other chemotherapy drugs be used.
- HB≥90g/L,ANC(Absolute Neutrophil Count) ≥1.5×109/L；PLT ≥100×109/L ,BIL/ALT/AST(aspartate aminotransferase )/Cr in normal range,or CCR≥60ml/min,TG≤ 3.0mmol/L，cholesterol≤7.75mmol/L; LVEF≥LLN.
- 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.
- Volunteer, informed consent form (ICF) signed, compliance.
Who cannot join
- Subject was diagnosed with other malignant tumors previously or meanwhile;
- Participated in other clinical trials in four weeks;
- Has influence of oral drugs(such as unable to swallow, gastrointestinal tract after resection);
- Already diagnosed with brain metastases, spinal cord compression, cancerous meningitis, or screening CT or MRI findings of the brain or soft meningeal disease patient;
- Hypertension
- Urine protein: ++, and urinary in 24 hours > 1.0g;
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- Coagulant function abnormality: subject with bleeding tendency (such as active peptic ulcer) or are receiving thrombolysis or anticoagulant therapy;
- Subject with psychiatric drugs abuse history and can't get rid of, or mental disorder;
- With artery/venous thrombotic before oral ALTN;
- With history of anticoagulant, vitamin K antagonists(such as warfarin or heparin) or other analogues treatment;
- With Abnormal thyroid function;
- With history of psychiatric drugs abuse or a mental disorder;
- Viral hepatitis B or hepatitis c patients (including hepatitis b, hepatitis c virus carriers);
- Have immunodeficiency history;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.
ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis.
Read the detailed description
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.
- Conditions
- Advanced Cancer
- Being tested
- anlotinib
- Keywords
- Advanced cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anlotinibDrug
Also called ALTN
oral medicine.
| Study group | Role | What they receive |
|---|---|---|
| anlotinib | Experimental | dosage form:capsule dosage:5mg,10mg,16mg,12mg frequency:once one day duration:Continuous two weeks then stop a week Receives: Drug: anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax Cmax t1/2 AUC
To collect point with single drug:H0/H0.5/H1/H2/H4/H8/H12/H24/H48/H72/H96/H120/H144/H/H168/H192/H216/H240
To collect point with multiple drug:d1/d2/d4/d7/d10/d14/d15/d21/d22/d28/d35/d42
Measured: Up to 52 days
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
blood examination, urine examination, stool examination, blood biochemical (ALT, AST, TB(total bilirubin), DB, BUN, Cr, blood electrolyte), electrocardiogram (ecg), thyroid function, the function of blood coagulation, etc
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startMay 2011
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nanjing Medical University
- Responsible party
- Sponsor
- Investigators
- Yihebali Chi, doctor, Principal investigator, Cancer Institude and hospital,CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833923
- Sponsor's protocol ID
- ALTN-I-01
- Acronym
- ALTN
- Status last verified
- Oct 2015
- First submitted
- 29 Mar 2013
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes