Solid TumorPhase 2NCT05274191
An Exploratory Basket Study of Pyrotinib Maleate Tablets in HER2 Mutated or Amplified of Metastatic Solid Tumors
A Phase 2 study testing Pyrotinib Maleate and standard regimen in people with Solid Tumor, run by Zhongshan Hospital Xiamen University.
Trial summary
A single arm, open-label Phase II clinical study.The subjects were patients with lung, gastric and colorectal cancers. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Pyrotinib Maleate and standard regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2022to 15 Mar 2024
- Phase
- Phase 2
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age:18-75 years old, regardless of gender;
- Disease progression during the previous standard treatment or disease progression within 6 months after the end of treatment, patients with gastric and gastroesophageal junction adenocarcinoma requires previous use of trastuzumab, and other tumors must have received at least first-line standard chemotherapy ± targeted therapy.
- Two or more grade IV hematological toxicity or non-hematological toxicity ≥ grade III or damage to the heart, liver, kidney and other major organs of grade ≥ II occurred during the standard treatment process; Patients who have been confirmed by the doctor to no longer receive standard treatment can be included in the group.
- HER2 mutated non-small cell lung cancer , gastric and gastroesophageal junction adenocarcinoma or Adenocarcinoma of the colon has been confirmed by Pathology.
- Cancer tissue pathology is clearly HER2 positive: including IHC2+/ISH+, IHC 3+ or HER2 mutations (the results obtained by NGS method, PCR method, Sanger method, mass spectrometry sequencing and other measurement methods are all acceptable).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
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- For recurrent or metastatic tumours, according to the RECIST 1.1 standard, the subject has at least one measurable target disease.
- Life expectancy greater than or equal to 12 months;
- The functional level of organs must meet the following requirements:
- Blood routine: ANC ≥ 1.5×10^9/L; PLT ≥ 90×10^9/L; Hb ≥ 90 g/L; (2) Blood biochemistry: TBIL<=1.5×ULN; ALT and AST<=2×ULN; for subjects with liver metastases, ALT and AST<=5×ULN; BUN and Cr<=1.5×ULN and creatinine clearance ≥50mL/min (Cockcroft-Gault formula); (3) Heart color Doppler ultrasound: LVEF≥50%; (4) 12-lead electrocardiogram: The QT interval (QTcF) corrected by Fridericia's method is <450ms for males and <470ms for females.
- 10. Have sufficient bone marrow, liver and kidney functions. 11. Women of childbearing age and their spouses are willing to contraception during treatment and within 1 year after the last medication.
- Volunteer to join the study, sign an informed consent form, have good compliance and are willing to cooperate with follow-up.
Who cannot join
- 1. Left ventricular ejection fraction (LVEF) < 50% at baseline (measured by echocardiography or MUGA); 2. Patients who have received systemic therapy including immunotherapy, biotherapy and any clinical trial drugs in the past 2 weeks; 3. Patients with uncontrollable central metastases, brain tumor lesions confirmed by brain CT or MRI and need dehydration treatment or radiotherapy (except for patients with stable brain metastases after 1 month of radiotherapy); 4. With > grade 1 unresolved toxicity due to any previous treatment / procedure (ctc-ae, except alopecia, anemia, and hypothyroidism); 5. Severe infection and other serious systemic diseases; 6. Patients receiving long-term or high-dose corticosteroid treatment (inhaled steroids or short-term oral steroids are allowed to resist vomiting or promote appetite); 7. Evidence or history of coagulation disorders such as bleeding events with grade ≥ 3 (ctc-ae); 8. Patients whom intestinal obstruction and other factors affecting oral administration or absorption of drugs; After the comprehensive judgment of the disease, the researcher thought that it was not suitable to participate in this study.
Trial locations and contacts
No sites are listed yet.
About this study
A single arm, open-label Phase II clinical study.The subjects were patients with lung, gastric and colorectal cancers.
Read the detailed description
Object: 1.The main purpose: T To observe and evaluate the efficacy of pyrotinib in patients with HER2-mutated/amplified metastatic solid tumors after failure of standard therapy; 2. Secondary objectives: To observe and evaluate the safety of pyrotinib in patients in HER2 mutated or amplified metastatic solid tumors after failure of standard treatment.
- Conditions
- Solid Tumor
- Being tested
- Pyrotinib Maleate, standard regimen
- Keywords
- HER2 mutation or amplification,Pyrotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrotinib MaleateDrug
Pyrotinib ± standard regimen Pyrotinib: 400 mg/day (once a day, orally at the same time every day), continued until disease progression;
standard regimenOther
standard regimen
| Study group | Role | What they receive |
|---|---|---|
| A single arm, open-label Phase II clinical study. | Experimental | All subjects enrolled will receive the following treatment：Pyrotinib±standard treatment.
Pyrotinib 400 mg/ D (once a day, at the same time each day) until the progression of disease; Chemotherapy regimens follow the programme cycle recommended by the guidelines or as determined by the investigator.
The dosage can be adjusted according to the protocol according to the adverse reactions of subjects. Subjects will continue to take medication until completion of the prescribed course of treatment, disease progression, toxicity intolerance, withdrawal of Informed Consent Form, or termination in the investigator's judgment. Receives: Drug: Pyrotinib Maleate; Other: standard regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Defined as proportion of complete response and partial response according to RECIST 1.1 criteria.
Measured: 24 months
Secondary outcomes (3)
Overall survival
Defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.
Measured: 24 months
Disease control rate
the proportion of patients whose tumors shrink or remain stable for a certain period of time, including complete remission (CR), partial remission (PR) and stable (SD) cases
Measured: 24 months
Progression-free survival
Defined as the time from the date of informed consent to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start4 Mar 2022 (estimated)
- Primary completion15 Mar 2022 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Hospital Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- li xiao, Principal investigator, Zhongshan Hospital Affiliated to Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274191
- Sponsor's protocol ID
- 2022-228
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Basket Study of Pyrotinib Maleate Tablets in HER2 Mutated or Amplified of Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05274191
- Acronym / sponsor ID
- 2022-228
- Conditions
- Solid Tumor
- Keywords
- HER2 mutation or amplification,Pyrotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhongshan Hospital Xiamen UniversityUniversity, hospital or other
- Study start
- 4 Mar 2022 (estimated)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 10 Mar 2022 (actual)
- 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.
A single arm, open-label Phase II clinical study.The subjects were patients with lung, gastric and colorectal cancers.
Detailed description
Object: 1.The main purpose: T To observe and evaluate the efficacy of pyrotinib in patients with HER2-mutated/amplified metastatic solid tumors after failure of standard therapy; 2. Secondary objectives: To observe and evaluate the safety of pyrotinib in patients in HER2 mutated or amplified metastatic solid tumors after failure of standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A single arm, open-label Phase II clinical study. | Experimental | Drug: Pyrotinib Maleate, Other: standard regimenAll subjects enrolled will receive the following treatment：Pyrotinib±standard treatment. Pyrotinib 400 mg/ D (once a day, at the same time each day) until the progression of disease; Chemotherapy regimens follow the programme cycle recommended by the guidelines or as determined by the investigator. The dosage can be adjusted according to the protocol according to the adverse reactions of subjects. Subjects will continue to take medication until completion of the prescribed course of treatment, disease progression, toxicity intolerance, withdrawal of Informed Consent Form, or termination in the investigator's judgment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age:18-75 years old, regardless of gender;
- Disease progression during the previous standard treatment or disease progression within 6 months after the end of treatment, patients with gastric and gastroesophageal junction adenocarcinoma requires previous use of trastuzumab, and other tumors must have received at least first-line standard chemotherapy ± targeted therapy.
- Two or more grade IV hematological toxicity or non-hematological toxicity ≥ grade III or damage to the heart, liver, kidney and other major organs of grade ≥ II occurred during the standard treatment process; Patients who have been confirmed by the doctor to no longer receive standard treatment can be included in the group.
- HER2 mutated non-small cell lung cancer , gastric and gastroesophageal junction adenocarcinoma or Adenocarcinoma of the colon has been confirmed by Pathology.
- Cancer tissue pathology is clearly HER2 positive: including IHC2+/ISH+, IHC 3+ or HER2 mutations (the results obtained by NGS method, PCR method, Sanger method, mass spectrometry sequencing and other measurement methods are all acceptable).
Key exclusion criteria (1 listed)
- 1. Left ventricular ejection fraction (LVEF) < 50% at baseline (measured by echocardiography or MUGA); 2. Patients who have received systemic therapy including immunotherapy, biotherapy and any clinical trial drugs in the past 2 weeks; 3. Patients with uncontrollable central metastases, brain tumor lesions confirmed by brain CT or MRI and need dehydration treatment or radiotherapy (except for patients with stable brain metastases after 1 month of radiotherapy); 4. With > grade 1 unresolved toxicity due to any previous treatment / procedure (ctc-ae, except alopecia, anemia, and hypothyroidism); 5. Severe infection and other serious systemic diseases; 6. Patients receiving long-term or high-dose corticosteroid treatment (inhaled steroids or short-term oral steroids are allowed to resist vomiting or promote appetite); 7. Evidence or history of coagulation disorders such as bleeding events with grade ≥ 3 (ctc-ae); 8. Patients whom intestinal obstruction and other factors affecting oral administration or absorption of drugs; After the comprehensive judgment of the disease, the researcher thought that it was not suitable to participate in this study.
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 |
|---|---|---|
| Pyrotinib MaleatePyrotinib ± standard regimen Pyrotinib: 400 mg/day (once a day, orally at the same time every day), continued until disease progression; | Drug | A single arm, open-label Phase II clinical study. |
| standard regimenstandard regimen | Other | A single arm, open-label Phase II clinical study. |
Primary outcome
Objective response rate
Time frame: 24 months
Defined as proportion of complete response and partial response according to RECIST 1.1 criteria.
3 secondary outcomes
Overall survival
Time frame: 24 months
Disease control rate
Time frame: 24 months
Progression-free survival
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
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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.
li xiao principal investigator
Zhongshan Hospital Affiliated to Xiamen University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pyrotinib Maleate and standard regimen in people with Solid Tumor, run by Zhongshan Hospital Xiamen University.
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 12 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact li xiao, phd (13906036392, xiaolibohan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 24 months). 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 10 Mar 2022.