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


Phase 1
18 Years
65 Years
Open (Enrolling)
Both
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
5mg/d,10mg/d,16mg/d,12mg.


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
months.

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
resection);

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

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
disorder;

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
carriers);

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
trial.

Type of Study:

Interventional

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:

No

Principal Investigator

Yihebali Chi, doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institude and hospital,CAMS

Authority:

China: Food and Drug Administration

Study ID:

ALTN-I-01

NCT ID:

NCT01833923

Start Date:

May 2011

Completion Date:

November 2013

Related Keywords:

  • Advanced Cancer
  • Advanced cancer
  • Neoplasms

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