NCT01833923

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

4.4 years

First QC Date

March 29, 2013

Last Update Submit

October 27, 2015

Conditions

Advanced Cancer

Keywords

Advanced cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Up to 21 days

Other Outcomes (1)

  • tumor size

    Up to 42 days

Study Arms (1)

anlotinib

EXPERIMENTAL

dosage form:capsule dosage:5mg,10mg,16mg,12mg frequency:once one day duration:Continuous two weeks then stop a week

Drug: anlotinib

Interventions

anlotinibDRUG

oral medicine.

Also known as: ALTN
anlotinib

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • late malignant tumor patients diagnosed with the pathological and/or cytological;
  • lack of the standard treatment or treatment failure;
  • years, ECOG:0-1,Expected survival period \>3 months;
  • stop medicine \> 30 days if any other chemotherapy drugs be used.
  • 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.
  • 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.
  • Volunteer, informed consent form (ICF) signed, compliance.

You may not qualify if:

  • Subject was diagnosed with other malignant tumors previously or meanwhile;
  • Participated in other clinical trials in four weeks;
  • Has influence of oral drugs(such as unable to swallow, gastrointestinal tract after resection);
  • Already diagnosed with brain metastases, spinal cord compression, cancerous meningitis, or screening CT or MRI findings of the brain or soft meningeal disease patient;
  • Hypertension
  • Urine protein: ++, and urinary in 24 hours \> 1.0g;
  • Coagulant function abnormality: subject with bleeding tendency (such as active peptic ulcer) or are receiving thrombolysis or anticoagulant therapy;
  • Subject with psychiatric drugs abuse history and can't get rid of, or mental disorder;
  • With artery/venous thrombotic before oral ALTN;
  • With history of anticoagulant, vitamin K antagonists(such as warfarin or heparin) or other analogues treatment;
  • With Abnormal thyroid function;
  • With history of psychiatric drugs abuse or a mental disorder;
  • Viral hepatitis B or hepatitis c patients (including hepatitis b, hepatitis c virus carriers);
  • Have immunodeficiency history;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Interventions

anlotinib

Study Officials

  • Yihebali Chi, doctor

    Cancer Institude and hospital,CAMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2013

First Posted

April 17, 2013

Study Start

May 1, 2011

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 28, 2015

Record last verified: 2015-10

Locations

CN(1)