Clinical trial NCT01833923: A Phase I Study of Anlotinib on Tolerance and Pharmacokinetics
Official title: A Phase I Study of Anlotinib on Tolerance and Pharmacokinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: Advanced cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Nanjing Medical University
First posted: 2013-04-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tmax Cmax t1/2 AUC
timeFrame: Up to 52 days
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 21 days
Other outcomes:
measure: tumor size
timeFrame: Up to 42 days
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institude and hospital,CAMS
name: Yihebali Chi, doctor
role: PRINCIPAL_INVESTIGATOR
References: