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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Anlotinib on Tolerance and Pharmacokinetics
- ClinicalTrials.gov ID
- NCT01833923
- Acronym / sponsor ID
- ALTN / ALTN-I-01
- Conditions
- Advanced Cancer
- Keywords
- Advanced cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nanjing Medical University
- Study start
- May 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anlotinib | Experimental | Drug: anlotinibdosage form:capsule dosage:5mg,10mg,16mg,12mg frequency:once one day duration:Continuous two weeks then stop a week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anlotinibAlso: ALTNoral medicine. | Drug | anlotinib |
Primary outcome
Tmax Cmax t1/2 AUC
Time frame: Up to 52 days
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
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yihebali Chi, doctor principal investigator
Cancer Institude and hospital,CAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tmax Cmax t1/2 AUC (time frame: Up to 52 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.