MedTrace Logo

Dose Finding and Pharmacokinetics/Pharmacodynamics Study of Apatinib in the Treatment of Advanced Colorectal Cancer

NCT01531777 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-04-03

No results posted yet for this study

Summary

RATIONALE:

Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable.

PURPOSE:

1. Studying how well Apatinib works in treating patients.
2. Finding the efficacy and safety of 500 mg or 750mg Apatinib.
3. Pharmacokinetics/Pharmacodynamics(PK/PD).
4. Exploring new outcome measures of antiangiogenic drugs.

Conditions

Interventions

DRUG

Apatinib

500 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.

DRUG

apatinib

750 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jin Li, MD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01531777 on ClinicalTrials.gov