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CancerPhase 1NCT02752516

A Phase I Additional Study of Anlotinib on Tolerance and Pharmacokinetics

A Phase 1 study testing Anlotinib in people with Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A Phase I Additional Study of Anlotinib on Tolerance and Pharmacokinetics.To further study the pharmacokinetic characteristics of Anlotinib in the human body, recommend a reasonable regimen for subsequent research. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cancer
What is being tested?
Anlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
27 Apr 2016to Dec 2017
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

  • Histological documentation of Advanced solid tumors except the digestive tract tumors,at least one measurable lesion (by RECIST1.1)
  • Lack of the standard treatment or treatment failure
  • 18-65 years,ECOG PS:0-1,Life expectancy of more than 3 months
  • 30 Days or more from the last cytotoxic therapy
  • 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

  • Patients who are used by anlotinib
  • Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
  • Brain metastases patients with symptoms or symptoms controlled < 3 months
  • Patients with any severe and/or unable to control diseases，including：
  • Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
  • Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥480ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);
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  • Patients with active or unable to control serious infections;
  • Patients with cirrhosis, decompensated liver disease, or active hepatitis;
  • Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)
  • Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed
  • Patients with non-healing wounds or fractures
  • Patients with any CTC AE Grade 1 or higher bleeding events occurred in the lungs or any CTC AE Grade 2 or higher bleeding events occurred within 4 weeks prior to assignment;Patients with any physical signs of bleeding diathesis or receiving thrombolysis and anticoagulation
  • 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
  • History of immunodeficiency
  • 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.

China1 site

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: Phase I Additional Study of Tolerance and Pharmacokinetics of Anlotinib in Patients With Advanced Solid Tumors

A Phase I Additional Study of Anlotinib on Tolerance and Pharmacokinetics.To further study the pharmacokinetic characteristics of Anlotinib in the human body, recommend a reasonable regimen for subsequent research.

Conditions
Cancer
Being tested
Anlotinib
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnlotinibDrug

    Anlotinib QD po. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Study groups in NCT02752516
Study groupRoleWhat they receive
AnlotinibExperimentalNot described
Receives: Drug: Anlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics of Anlotinib (in whole blood):Peak Plasma Concentration(Cmax)

    Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H72/H120/H168/H240（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle（D means Day）.

    Measured: up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

  2. Pharmacokinetics of Anlotinib (in whole blood):Peak time（Tmax）

    Peak time（Tmax）,Tmax in h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H72/H120/H168/H240(H means hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day).

    Measured: up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

  3. Pharmacokinetics of Anlotinib (in whole blood):Half life（t1/2）

    Half life（t1/2）,t1/2 in h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H72/H120/H168/H240(H mans Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day).

    Measured: up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

  4. 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 of single-dose, full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H72/H120/H168/H240(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day).

    Measured: up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

  5. Pharmacokinetics of Anlotinib (in whole blood):Clearance（CL）

    Clearance（CL）,CL in L/h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H72/H120/H168/H240(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day).

    Measured: up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

  6. Cumulative excretion of Anlotinib (in urine)

    Measured: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)

Secondary outcomes (1)

  1. Objective Response Rate (ORR)

    Measured: each 42 days up to intolerance the toxicity or PD(Disease progression) (up to 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2016 (estimated)
  2. Study start27 Apr 2016
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02752516
Sponsor's protocol ID
ALTN-I-07
Status last verified
Apr 2017
First submitted
25 Apr 2016
Last updated
18 Sep 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anlotinib in people with 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 16 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: status not confirmed, as of the sponsor's last update on 18 Sep 2017. 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?

Results are not available in the source record.

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 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02752516.

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 18 Sep 2017.

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