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Study of Cipatinib in Patients With HER2 Positive or Uncertain Advanced Breast Cancer

NCT01301911 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2012-12-21

No results posted yet for this study

Summary

Cipatinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the safety and tolerability of cipatinib in patients with HER2 positive or uncertain advanced breast cancer:

1. To evaluate the safety and tolerability of cipatinib, and the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT)
2. To determine the pharmacokinetic profile of cipatinib and its metabolites
3. To assess preliminary antitumor activity
4. To determine preliminary regimen for phase II study
5. To determine the relation of expression of HER-1 and HER-2 to the antitumor activity.

Conditions

Interventions

DRUG

Cipatinib

Cipatinib either at 200, 400, 800, 1200, 1400, 1600 or 1800 mg, p.o. once daily

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    collaborator OTHER

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-11-30
Completion
2012-11-30

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 NCT01301911 on ClinicalTrials.gov