- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01301911
Study of Cipatinib in Patients With HER2 Positive or Uncertain Advanced Breast Cancer
December 20, 2012 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Phase I Study of Cipatinib in Patients With HER2 Positive or Uncertain Advanced Breast Cancer
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:
- To evaluate the safety and tolerability of cipatinib, and the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT)
- To determine the pharmacokinetic profile of cipatinib and its metabolites
- To assess preliminary antitumor activity
- To determine preliminary regimen for phase II study
- To determine the relation of expression of HER-1 and HER-2 to the antitumor activity.
Study Overview
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100021
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Aged ≥ 18 and ≤ 65 years.
- ECOG performance status of 0 to 1.
- Life expectancy of more than 3 months.
- Histologically or cytologic confirmed HER2 positive or uncertain advanced breast cancer that is not curable with available therapies.
Screening laboratory values within the following parameters:
- ANC: ≥ 1.5 x 109/L
- Platelet count: ≥ 100 x 109/L
- Hemoglobin: ≥ 9.0 g/dL
- Serum albumin: ≥ 2.5 g/dL
- Total bilirubin: ≤ 1.5 x upper limit of normal, ULN
- ALT and AST: ≤ 1.5 x ULN
- Serum creatinine: ≤ 1.0 x ULN
- Creatinie clearnce rate: ≥ 50 mL/min
- Cholesterol≤7.75 mmol/L and triglyceride≤2.5 x ULN
- LVEF: ≥ 50%
- QTcF: < 470 ms
- Recovery from all clinically significant AEs related to prior therapies. Duration from the latest therapy is more than 6 weeks for nitroso or mitomycin, or more than 4 weeks for operation, radiotherapy, cytotoxic agents or molecular targeting.
- Ability or willingness to swallow tablets, no dysfunction of gastrointestinal absorption.
- All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. For women of child bearing potential, a negative urine or serum pregnancy test result before initiating cipatinib.
- Signed informed consent.
Exclusion Criteria:
- Subjects with third space fluid that can not be controled by drainage or other methods.
- Steroid treatment for more than 50 days, or in need of long-term use of steroids.
- Subjects with uncontrol hypokalemia and hypomagniesemia before study entry.
- Subjects can not interrupt the using of the drugs that may cause QT prolongation during study.
- Subjects with meningioma, or with active central nervous system metastases as indicated by clinical symptoms.
- Subjects with liver metastases which ALT or AST > 1.5 x ULN.
- Treated or treating with EGFR or HER2 TKIs before study entry.
- Receiving any other antitumor therapy.
- Less than 4 weeks from the last clinical trial.
- Pregnant or breastfeeding women.
- Known history of hypersensitivity to cipatinib or any of it components.
- Ongoing infection (determined by investigator).
- Subjects had any heart disease: coronary artery disease, arrhythmia need to treat, heart failure, LVEF < 50%, and any other heart disease that is determined as unfit for this study by investigator, etc.
- Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study. Examples include, but are not limited to, hypertension, severe diabetes, or thyroid disease.
- Known history of neurological or psychiatric disease, including epilepsy or dementia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Cipatinib
Each subject will receive a single dose of cipatinib on treatment day 1, followed by 4-day observation period, and then will receive cipatinib once daily in cycles consisting of 21 days.
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Cipatinib either at 200, 400, 800, 1200, 1400, 1600 or 1800 mg, p.o. once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The maximum-tolerated dose (MTD) regimen of cipatinib will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) after completing one treatment cycle.
Time Frame: 3 weeks
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3 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with adverse events.
Time Frame: 6 weeks
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6 weeks
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Cipatinib pharmacokinetic parameters may include AUC, Cmax, Tmax, and t1/2.
Time Frame: 3 weeks
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3 weeks
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Objective response rate (ORR).
Time Frame: 6 weeks
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6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (ACTUAL)
November 1, 2012
Study Completion (ACTUAL)
November 1, 2012
Study Registration Dates
First Submitted
January 28, 2011
First Submitted That Met QC Criteria
February 20, 2011
First Posted (ESTIMATE)
February 23, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
December 21, 2012
Last Update Submitted That Met QC Criteria
December 20, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XPTN-Ia-1.0
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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