Advanced CancerPhase 1NCT02825563
A Phase I Study of Anlotinib on Pharmacokinetics to Assess the Effect of High Fat Diet in Advanced Cancer Patients
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
The purpose of this study is to further study the pharmacokinetic characteristics of Anlotinib in Advanced Cancer Patients with High Fat Diet. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to 15 Aug 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological documentation of Advanced solid tumors( Non-small Cell Lung Cancer.Soft Tissue SarcomaMedullary. Thyroid Carcinoma)
- At least one measurable lesion (by RECIST1.1)
- Lack of the standard treatment or treatment failure
- 20≤BMI≤25
- 18-70 years,ECOG PS:0-1,Life expectancy of more than 3 months
- Main organs function is normal
- Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
- Patients should participate in the study voluntarily and sign informed consent
Who cannot join
- Clear allergies to the study drug or its ingredients
- Had the disease to affect drug absorption and metabolism
- Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
- Brain metastases patients with symptoms or symptoms controlled < 1 months
- Used any drugs inhibit or induce hepatic drug metabolic enzymes in 30 days before the study
- Patients with drug abuse history and unable to get rid of or Patients with mental disorders
- Patients participated in other anticancer drug clinical trials within 4 weeks
- Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Additional Study of Anlotinib on Pharmacokinetics to Assess the Effect of High Fat Diet in Advanced Cancer Patients
The purpose of this study is to further study the pharmacokinetic characteristics of Anlotinib in Advanced Cancer Patients with High Fat Diet.
- Conditions
- Advanced Cancer
- Being tested
- Anlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib(In the fasting state) | Experimental | In the fasting state, Anlotinib po only once and after 14 days it could be continued by Qd po.until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Drug: Anlotinib |
| Anlotinib(In the high fat diet state) | Experimental | In the high fat diet state, Anlotinib po only once and after 14 days it could be continued by Qd po.until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of Anlotinib (in whole blood):Peak Plasma Concentration(Cmax)
Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study , full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H96/H144/H192/H240/H336(H mans Hour).
Measured: up to 14 Days
Pharmacokinetics of Anlotinib (in whole blood):Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.In the study , full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H96/H144/H192/H240/H336(H mans Hour).
Measured: up to 14 Days
Secondary outcomes (1)
Pharmacokinetics of Anlotinib (in whole blood):Peak time（Tmax）
Peak time（Tmax）,Tmax in h.In the study , full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H96/H144/H192/H240/H336(H mans Hour).
Measured: up to 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJun 2016
- Primary completion15 Aug 2018
- Study completion15 Aug 2018
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825563
- Sponsor's protocol ID
- ALTN-I-05
- Status last verified
- May 2019
- First submitted
- 29 Jun 2016
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Additional Study of Anlotinib on Pharmacokinetics to Assess the Effect of High Fat Diet in Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT02825563
- Acronym / sponsor ID
- ALTN-I-05
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 7 Jul 2016 (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.
The purpose of this study is to further study the pharmacokinetic characteristics of Anlotinib in Advanced Cancer Patients with High Fat Diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib(In the fasting state) | Experimental | Drug: AnlotinibIn the fasting state, Anlotinib po only once and after 14 days it could be continued by Qd po.until disease progression or intolerable toxicity or patients withdrawal of consent |
| Anlotinib(In the high fat diet state) | Experimental | Drug: AnlotinibIn the high fat diet state, Anlotinib po only once and after 14 days it could be continued by Qd po.until disease progression or intolerable toxicity or patients withdrawal of consent |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histological documentation of Advanced solid tumors( Non-small Cell Lung Cancer.Soft Tissue SarcomaMedullary. Thyroid Carcinoma)
- At least one measurable lesion (by RECIST1.1)
- Lack of the standard treatment or treatment failure
- 20≤BMI≤25
- 18-70 years,ECOG PS:0-1,Life expectancy of more than 3 months
Key exclusion criteria (8 listed)
- Clear allergies to the study drug or its ingredients
- Had the disease to affect drug absorption and metabolism
- Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
- Brain metastases patients with symptoms or symptoms controlled < 1 months
- Used any drugs inhibit or induce hepatic drug metabolic enzymes in 30 days before the study
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 |
|---|---|---|
| Anlotinibin the fasting state | Drug | Anlotinib(In the fasting state) |
| Anlotinibin the high fat diet | Drug | Anlotinib(In the high fat diet state) |
Primary outcome
Pharmacokinetics of Anlotinib (in whole blood):Peak Plasma Concentration(Cmax)
Time frame: up to 14 Days
Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study , full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H96/H144/H192/H240/H336(H mans Hour).
Pharmacokinetics of Anlotinib (in whole blood):Area under the plasma concentration versus time curve (AUC)
Time frame: up to 14 Days
Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.In the study , full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H96/H144/H192/H240/H336(H mans Hour).
1 secondary outcome
Pharmacokinetics of Anlotinib (in whole blood):Peak time（Tmax）
Time frame: up to 14 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 22 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 8 inclusion and 8 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 22 May 2019. 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?
Pharmacokinetics of Anlotinib (in whole blood):Peak Plasma Concentration(Cmax) (time frame: up to 14 Days). The study lists 2 primary outcomes in all. 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 22 May 2019.