Breast CancerPhase 1NCT01301911
Study of Cipatinib in Patients With HER2 Positive or Uncertain Advanced Breast Cancer
A Phase 1 study testing Cipatinib in people with Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cipatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Cipatinib
- Keywords
- Breast cancer, Advanced, Cipatinib, phase I, HER2 positive or uncertain advanced breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CipatinibDrug
Cipatinib either at 200, 400, 800, 1200, 1400, 1600 or 1800 mg, p.o. once daily
| Study group | Role | What they receive |
|---|---|---|
| Cipatinib | Experimental | 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. Receives: Drug: Cipatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (3)
Number of participants with adverse events.
Measured: 6 weeks
Cipatinib pharmacokinetic parameters may include AUC, Cmax, Tmax, and t1/2.
Measured: 3 weeks
Objective response rate (ORR).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301911
- Sponsor's protocol ID
- XPTN-Ia-1.0
- Status last verified
- Dec 2012
- First submitted
- 28 Jan 2011
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Cipatinib in Patients With HER2 Positive or Uncertain Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01301911
- Acronym / sponsor ID
- XPTN-Ia-1.0
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Advanced, Cipatinib, phase I, HER2 positive or uncertain advanced breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cipatinib | Experimental | Drug: CipatinibEach 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CipatinibCipatinib either at 200, 400, 800, 1200, 1400, 1600 or 1800 mg, p.o. once daily | Drug | Cipatinib |
Primary outcome
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
3 secondary outcomes
Number of participants with adverse events.
Time frame: 6 weeks
Cipatinib pharmacokinetic parameters may include AUC, Cmax, Tmax, and t1/2.
Time frame: 3 weeks
Objective response rate (ORR).
Time frame: 6 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cipatinib in people with Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2012.