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A Phase I Study of Anlotinib on Pharmacokinetics to Assess the Effect of High Fat Diet in Advanced Cancer Patients

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ClinicalTrials.gov Identifier: NCT02825563
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study Description
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Brief Summary:
The purpose of this study is to further study the pharmacokinetic characteristics of Anlotinib in Advanced Cancer Patients with High Fat Diet.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: Anlotinib Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Additional Study of Anlotinib on Pharmacokinetics to Assess the Effect of High Fat Diet in Advanced Cancer Patients
Actual Study Start Date : June 2016
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : August 15, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Anlotinib(In the fasting state)
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
 Drug: Anlotinib
in the fasting state
Experimental: Anlotinib(In the high fat diet state)
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
 Drug: Anlotinib
in the high fat diet


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. Pharmacokinetics of Anlotinib (in whole blood):Peak time（Tmax） [ Time Frame: up to 14 Days ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825563


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
More Information
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT02825563    
Other Study ID Numbers: ALTN-I-05
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Neoplasms