HER2 Positive Breast CancerPhase 1NCT02476539
Study Evaluating Hemay022 In Subjects With HER2-Positive Advanced Breast Cancer
A Phase 1 study testing Hemay022 in people with HER2 Positive Breast Cancer, run by Tianjin Hemay Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The purposes of this study are to assess the safety, tolerability and pharmacokinetics of Hemay022. The secondary purpose of this study is to assess the efficacy of Hemay022 in the treatment of HER2-positive advanced breast cancer. The study will be conducted in two parts. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HER2 Positive Breast Cancer
- What is being tested?
- Hemay022
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2015to 30 Sep 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 to 65 years;
- Histologically or cytologically confirmed and radiologically diagnosed advanced breast cancer subjects; and subjects who have failed standard therapy，or no effective therapy available for such subjects
- HER2 over-expression by IHC with score of 3+, or 2+ with FISH confirmation;
- Preferably measurable tumour lesion as defined by RECIST criteria1.1;
- Subjects have received chemotherapy at least 4 weeks prior to screening (at least 6 weeks of washout time frame if treated with mitomycin and nitrosoureas) and must have recovered from any toxic effects of the treatment --- to CTCAE 4.03≤ Grade 1;
- ECOG Performance Status of 0,1;
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- Life expectancy of at least three months;
- Adequate bone marrow, liver, kidney function, meeting the following creteria:
- ANC≥1.5×109/L, HB≥90g/L, PLT≥75×109/L； TBIL≤1.5×ULN, ALT≤1.5×ULN, AST≤1.5×ULN; Cr ≤1×ULN; BUN ≤1×ULN;
- Left ventricular ejection fraction (LVEF) ≧50% as measured by Ultrasonic cardiogram (UCG)
- All female and male subjects must agree and commit to the use of a reliable contraceptive regimen for the duration of the study and for at least 12 weeks after at the last dose of test article. Female subjects must have a negative serum or urine pregnancy test performed within 7 days prior to treatment;
- Ability to understand and the be willingness to sign a written informed consent before study entry;
- subjects would have good communication with the investigator and could comply with protocol
Who cannot join
- Patients with parenteral nutrition; malabsorption syndrome; or any condition possibly affecting drug absorption or inability to tolerate oral medications;
- Clinically QTc prolongation, ventricular tachycardia, ventricular fibrillation, heart block, myocardial infarction within 1 year, congestive heart failure, symptoms requiring medicine treatment patients with coronary heart disease;
- Ventricular ejection fraction (LVEF) <50％;
- Active infection (ie, requiring intravenous antibiotic or antiviral agent);
- Active central nervous system metastases
- Have received other clinical trials treatment within the 4 weeks prior to study;
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- Have received other target therapy within the 4 weeks prior to study;
- Pregnant or breast feeding women;
- Have a known hypersensitivity to the test article or any of the excipient of the test article;
- Evidence of significant medical illness or abnormal laboratory finding that would make the subject inappropriate for this study by the investigator's judgment.
- Subjects cannot complete the study due to other reasons
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: An Ascending Single and Multiple Dose Study of the Pharmacokinetics, Safety and Tolerability of the Irreversible Epidermal Growth Factor Receptor Inhibitor Hemay022 in Patients With HER2-Positive Advanced Breast Cancer
The purposes of this study are to assess the safety, tolerability and pharmacokinetics of Hemay022. The secondary purpose of this study is to assess the efficacy of Hemay022 in the treatment of HER2-positive advanced breast cancer.
The study will be conducted in two parts. Part one, trial will be conducted in 18-30 subjects to determine safety and tolerability of Hemay022 in patients with HER2-positive advanced breast cancer. Part two, approximately 27 additional subjects with HER2-positive advanced breast cancer, are included to better define the tolerability and preliminary efficacy of Hemay022.
Read the detailed description
This is a phaseⅠsequential-group study of ascending single and multiple oral doses administered to subjects with HER2-Positive Advanced Breast Cancer. Each subject will receive a single dose of Hemay022, followed by a 1-week observation period, and then will receive Hemay022 administered once daily by mouth for 28 days. Each cycle consist of 28 days. Subjects will be enrolled in groups of 3 to 6. Depending on the safety and activity profile observed during the dose escalation phase, the dose selected for Part 2 may be adjusted. Part 2 is an extension part of three dose groups.
- Conditions
- HER2 Positive Breast Cancer
- Being tested
- Hemay022
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay022Drug
| Study group | Role | What they receive |
|---|---|---|
| Hemay022 | Experimental | Part one: Dose Escalation Group Hemay022 tablets will be taken orally once daily in doses of 50mg, 100mg, 200mg, 300mg,400mg or 500mg daily for 28 days.
Part two: Extension Group Hemay022 tablets will be taken in three dose groups that had been assessed by Part one for 28 days. Receives: Drug: Hemay022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: 4 weeks of treatment
Observed maximum concentration of Hemay022
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on day 1 and day 35
Time of maximum concentration of Hemay022
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on day 1 and day 35
Area under the plasma concentration versus time curve of Hemay022
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on day 1 and day 35
Trough Plasma Concentrations of Hemay022
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on day 1 and day 35
Predose plasma concentration
Measured: Predose on day 7, 14, 21
Secondary outcomes (2)
Disease control rate (complete response rate + partial response rate + stable disease rate) according to RECIST v1.1
Measured: 4 weeks of treatment
Objective response rate (complete response rate + partial response rate) according to RECIST v1.1
Measured: 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study start14 Oct 2015
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Positive Breast CancerStudies of the same condition, open and under way.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476539
- Sponsor's protocol ID
- Hemay022-002
- Status last verified
- Feb 2024
- First submitted
- 11 Jun 2015
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ascending Single and Multiple Dose Study of the Pharmacokinetics, Safety and Tolerability of the Irreversible Epidermal Growth Factor Receptor Inhibitor Hemay022 in Patients With HER2-Positive Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT02476539
- Acronym / sponsor ID
- Hemay022-002
- Conditions
- HER2 Positive Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Tianjin Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2015 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 19 Jun 2015 (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.
The purposes of this study are to assess the safety, tolerability and pharmacokinetics of Hemay022. The secondary purpose of this study is to assess the efficacy of Hemay022 in the treatment of HER2-positive advanced breast cancer.
The study will be conducted in two parts. Part one, trial will be conducted in 18-30 subjects to determine safety and tolerability of Hemay022 in patients with HER2-positive advanced breast cancer. Part two, approximately 27 additional subjects with HER2-positive advanced breast cancer, are included to better define the tolerability and preliminary efficacy of Hemay022.
Detailed description
This is a phaseⅠsequential-group study of ascending single and multiple oral doses administered to subjects with HER2-Positive Advanced Breast Cancer. Each subject will receive a single dose of Hemay022, followed by a 1-week observation period, and then will receive Hemay022 administered once daily by mouth for 28 days. Each cycle consist of 28 days. Subjects will be enrolled in groups of 3 to 6. Depending on the safety and activity profile observed during the dose escalation phase, the dose selected for Part 2 may be adjusted. Part 2 is an extension part of three dose groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemay022 | Experimental | Drug: Hemay022Part one: Dose Escalation Group Hemay022 tablets will be taken orally once daily in doses of 50mg, 100mg, 200mg, 300mg,400mg or 500mg daily for 28 days. Part two: Extension Group Hemay022 tablets will be taken in three dose groups that had been assessed by Part one for 28 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female subjects aged 18 to 65 years;
- Histologically or cytologically confirmed and radiologically diagnosed advanced breast cancer subjects; and subjects who have failed standard therapy，or no effective therapy available for such subjects
- HER2 over-expression by IHC with score of 3+, or 2+ with FISH confirmation;
- Preferably measurable tumour lesion as defined by RECIST criteria1.1;
- Subjects have received chemotherapy at least 4 weeks prior to screening (at least 6 weeks of washout time frame if treated with mitomycin and nitrosoureas) and must have recovered from any toxic effects of the treatment --- to CTCAE 4.03≤ Grade 1;
Key exclusion criteria (11 listed)
- Patients with parenteral nutrition; malabsorption syndrome; or any condition possibly affecting drug absorption or inability to tolerate oral medications;
- Clinically QTc prolongation, ventricular tachycardia, ventricular fibrillation, heart block, myocardial infarction within 1 year, congestive heart failure, symptoms requiring medicine treatment patients with coronary heart disease;
- Ventricular ejection fraction (LVEF) <50％;
- Active infection (ie, requiring intravenous antibiotic or antiviral agent);
- Active central nervous system metastases
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 |
|---|---|---|
| Hemay022 | Drug | Hemay022 |
Primary outcome
Number of participants with adverse events
Time frame: 4 weeks of treatment
Observed maximum concentration of Hemay022
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on day 1 and day 35
Time of maximum concentration of Hemay022
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on day 1 and day 35
Area under the plasma concentration versus time curve of Hemay022
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on day 1 and day 35
Trough Plasma Concentrations of Hemay022
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on day 1 and day 35
Predose plasma concentration
Time frame: Predose on day 7, 14, 21
2 secondary outcomes
Disease control rate (complete response rate + partial response rate + stable disease rate) according to RECIST v1.1
Time frame: 4 weeks of treatment
Objective response rate (complete response rate + partial response rate) according to RECIST v1.1
Time frame: 4 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
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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 Hemay022 in people with HER2 Positive Breast Cancer, run by Tianjin Hemay Pharmaceutical 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 13 inclusion and 11 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: finished, as of the sponsor's last update on 1 Mar 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with adverse events (time frame: 4 weeks of treatment). The study lists 6 primary outcomes in all. 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 1 Mar 2024.