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A Phase I Study of Anlotinib Hydrochloric Capsule on Tolerance and Pharmacokinetics

Phase 1
18 Years
65 Years
Open (Enrolling)
Advanced Cancer

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Trial Information

A Phase I Study of Anlotinib Hydrochloric Capsule on Tolerance and Pharmacokinetics

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

Inclusion Criteria:

1. late malignant tumor patients diagnosed with the pathological and/or cytological;

2. lack of the standard treatment or treatment failure;

3. 18-65years, ECOG:0-1,Expected survival period >3 months;

4. stop medicine > 30 days if any other chemotherapy drugs be used.

5. 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.

6. 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

7. Volunteer, informed consent form (ICF) signed, compliance.

Exclusion Criteria:

1. Subject was diagnosed with other malignant tumors previously or meanwhile;

2. Participated in other clinical trials in four weeks;

3. Has influence of oral drugs(such as unable to swallow, gastrointestinal tract after

4. Already diagnosed with brain metastases, spinal cord compression, cancerous
meningitis, or screening CT or MRI findings of the brain or soft meningeal disease

5. Hypertension

6. Urine protein: ++, and urinary in 24 hours > 1.0g;

7. Coagulant function abnormality: subject with bleeding tendency (such as active peptic
ulcer) or are receiving thrombolysis or anticoagulant therapy;

8. Subject with psychiatric drugs abuse history and can't get rid of, or mental

9. With artery/venous thrombotic before oral ALTN;

10. With history of anticoagulant, vitamin K antagonists(such as warfarin or heparin) or
other analogues treatment;

11. With Abnormal thyroid function;

12. With history of psychiatric drugs abuse or a mental disorder;

13. Viral hepatitis B or hepatitis c patients (including hepatitis b, hepatitis c virus

14. Have immunodeficiency history;

15. According to the researcher's judgment,there are concomitant diseases which will
seriously endanger the patients or obstruct the patients to complete the clinical

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tmax Cmax t1/2 AUC

Outcome Description:

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

Outcome Time Frame:

Up to 52 days

Safety Issue:


Principal Investigator

Yihebali Chi, doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institude and hospital,CAMS


China: Food and Drug Administration

Study ID:




Start Date:

May 2011

Completion Date:

November 2013

Related Keywords:

  • Advanced Cancer
  • Advanced cancer
  • Neoplasms