A Phase I Study of Anlotinib on Tolerance and Pharmacokinetics

Advanced Cancer Clinical Trial

— ALTN  

Official title:

A Phase I Study of Anlotinib on Tolerance and Pharmacokinetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833923
• Other study ID #: ALTN-I-01
• Status: Completed
• Phase: Phase 1
• First received: March 29, 2013
• Last updated: October 27, 2015
• Start date: May 2011
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.

ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Drug:
• anlotinib
oral medicine.

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd	Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	tumor size	To evaluate the effectiveness of ALTN by enhanced CT scan every two cycles. Refer to recist 1.1.	Up to 42 days	No
Primary	Tmax Cmax t1/2 AUC	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	Up to 52 days	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	blood examination, urine examination, stool examination, blood biochemical (ALT, AST, TB(total bilirubin), DB, BUN, Cr, blood electrolyte), electrocardiogram (ecg), thyroid function, the function of blood coagulation, etc	Up to 21 days	Yes