Colorectal CancerPhase 2NCT04380012
A Clinical Study of Pyrotinib in Patients With HER2-positive Advanced Colorectal Cancer
A Phase 2 study testing Pyrotinib and Pyrotinib in combination with trastuzumab in people with Colorectal Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To Observe the Efficacy and Safety of Pyrotinib Maleate in Patients With HER2-positive Advanced Colorectal Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Pyrotinib and Pyrotinib in combination with trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2019to 17 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Aged 18-75 years, male or female;
- 2. ECOG performance status 0-2;
- 3. Recurrent/metastatic advanced colorectal cancer diagnosed by histology or cytology;
- 4. Patients who progressed on or were intolerable to standard therapy, or those who refused chemotherapy;
- 5. At least one measurable lesion according to RECIST v1.1;
- 6. HER2 positivity (including amplification, mutation, and overexpression) detected by clinically recognized methods (including PCR, FISH, immunohistochemistry, and NGS), and the data obtained by NGS at the pathology department of hospital or qualified gene testing organization could be accepted;
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- 7.The functional level of the major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocytes- or platelet-raising drugs):
- Blood routine: neutrophils (ANC) ≥ 1.5 × 10^9 / L; platelet count (PLT) ≥ 90 × 10^9 / L; hemoglobin (Hb) ≥ 90 g / L;
- Blood biochemistry: total bilirubin (TBIL) ≤ upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × ULN（Patients with liver metastases were ≤5 × ULN）;
- Cardiac color doppler ultrasound: left ventricular ejection fraction (LVEF) ≥ 55%;
- 12-lead electrocardiogram: The QT interval corrected by the Fridericia method (QTcF) < 470 msec;
- 8. Sign the informed consent and agree to collect the clinical efficacy and information of the patient.
Who cannot join
- 1. The presence of third interstitial effusion (such as a large amount of pleural fluid and ascites) that cannot be controlled by drainage or other methods makes it impossible to evaluate the clinical treatment effect;
- 2. History of substance abuse and cannot be cured or with mental disorders;
- 3. Pregnant or lactating women; patients with fertility who are unwilling or unable to use effective contraception;
- 4. Severe concomitant disease, or unsuitable to participate in this study decided by the investigator.
- 5. Prior use of pyrotinib.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated hospital of Zhejiang University School of Medical
Hangzhou, Zhejiang, 310009
XianHua Fu, Doctor, 15858222675, fxh198501@163.com
About this study
Official title: Pyrotinib Maleate With or Without Trastuzumab in the Treatment of HER2-positive Advanced Colorectal Cancer: a Multicenter Clinical Trial
To Observe the Efficacy and Safety of Pyrotinib Maleate in Patients With HER2-positive Advanced Colorectal Cancer
Read the detailed description
This study is an investigator-initiated, open-label, two-cohort phase II trial, assessing the objective response rate (ORR) of pyrotinib monotherapy (Cohort 1) or in combination with trastuzumab (Cohort 2), in HER2-positive advanced colorectal cancer.
HER2 positivity is centrally established by immunohistochemistry (IHC) and silver in situ hybridization (SISH). To be HER2 eligible the original tumor, or the biopsied metastasis (whichever is last available), must be IHC 3+ or 2+ in more than 50% of cells, confirmed by SISH or fluorescence in situ hybridization (FISH) with a HER2:CEP17 ratio ≥ 2.0. For IHC a positive staining (3+) is defined as an intense membrane staining which can be circumferential, basolateral, or lateral of the tumor cells.
- Conditions
- Colorectal Cancer
- Being tested
- Pyrotinib, Pyrotinib in combination with trastuzumab
- Keywords
- HER2, Advanced Colorectal Cancer, Pyrotinib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrotinibDrug
Pyrotinib as interventions were used in patients with HER2-positive advanced colorectal cancer
Pyrotinib in combination with trastuzumabDrug
Pyrotinib in combination with trastuzumab as interventions were used in patients with HER2-positive advanced colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Single drug group | Experimental | Pyrotinib: 400 mg, po, qd, 21d for a treatment cycle Receives: Drug: Pyrotinib |
| Dual-targeted drug group | Experimental | Pyrotinib: 400 mg, po, qd, 21d for one treatment cycle; Trastuzumab: first dose 8 mg/kg, then 6 mg/kg, iv, q3w, 21d for one treatment cycle Receives: Drug: Pyrotinib in combination with trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The proportion of patients with complete response or partial response according to RECIST v1.1.
Measured: Approximately 24 months
Secondary outcomes (5)
Disease Control Rate
The proportion of patients with complete response, partial response or stable disease according to RECIST v1.1.
Measured: Approximately 24 months
Progression-Free Survival
Time from the initiation of treatment to disease progression or any-cause death.
Measured: Up to 2 years
Overall Survival
Time from the initiation of treatment to any-cause death.
Measured: Up to 2 years
Duration of Response
Time from complete response or partial response to disease progression or any-cause death.
Measured: Approximately 24 months
The Incidence of Adverse Events
Adverse Events and Serious Adverse Events were graded according to the NCI-CTCAE V5.0.
Measured: From the first drug administration to within 28 days for the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start17 Dec 2019
- Primary completion17 Dec 2021 (estimated)
- Study completion17 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Zhejiang Provincial People's Hospital, First Affiliated Hospital of Zhejiang University, Sir Run Run Shaw Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380012
- Sponsor's protocol ID
- IR2019001210
- Status last verified
- Feb 2021
- First submitted
- 4 Feb 2020
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data were Shared with the sub-center, and the preliminary efficacy results were to be submitted to the tumor conference
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pyrotinib Maleate With or Without Trastuzumab in the Treatment of HER2-positive Advanced Colorectal Cancer: a Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT04380012
- Acronym / sponsor ID
- IR2019001210
- Conditions
- Colorectal Cancer
- Keywords
- HER2, Advanced Colorectal Cancer, Pyrotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Zhejiang Provincial People's Hospital, First Affiliated Hospital of Zhejiang University, Sir Run Run Shaw Hospital
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 17 Dec 2021 (estimated)
- Study completion
- 17 Jun 2022 (estimated)
- First posted
- 8 May 2020 (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.
To Observe the Efficacy and Safety of Pyrotinib Maleate in Patients With HER2-positive Advanced Colorectal Cancer
Detailed description
This study is an investigator-initiated, open-label, two-cohort phase II trial, assessing the objective response rate (ORR) of pyrotinib monotherapy (Cohort 1) or in combination with trastuzumab (Cohort 2), in HER2-positive advanced colorectal cancer.
HER2 positivity is centrally established by immunohistochemistry (IHC) and silver in situ hybridization (SISH). To be HER2 eligible the original tumor, or the biopsied metastasis (whichever is last available), must be IHC 3+ or 2+ in more than 50% of cells, confirmed by SISH or fluorescence in situ hybridization (FISH) with a HER2:CEP17 ratio ≥ 2.0. For IHC a positive staining (3+) is defined as an intense membrane staining which can be circumferential, basolateral, or lateral of the tumor cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single drug group | Experimental | Drug: PyrotinibPyrotinib: 400 mg, po, qd, 21d for a treatment cycle |
| Dual-targeted drug group | Experimental | Drug: Pyrotinib in combination with trastuzumabPyrotinib: 400 mg, po, qd, 21d for one treatment cycle; Trastuzumab: first dose 8 mg/kg, then 6 mg/kg, iv, q3w, 21d for one treatment cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Aged 18-75 years, male or female;
- 2. ECOG performance status 0-2;
- 3. Recurrent/metastatic advanced colorectal cancer diagnosed by histology or cytology;
- 4. Patients who progressed on or were intolerable to standard therapy, or those who refused chemotherapy;
- 5. At least one measurable lesion according to RECIST v1.1;
Key exclusion criteria (5 listed)
- 1. The presence of third interstitial effusion (such as a large amount of pleural fluid and ascites) that cannot be controlled by drainage or other methods makes it impossible to evaluate the clinical treatment effect;
- 2. History of substance abuse and cannot be cured or with mental disorders;
- 3. Pregnant or lactating women; patients with fertility who are unwilling or unable to use effective contraception;
- 4. Severe concomitant disease, or unsuitable to participate in this study decided by the investigator.
- 5. Prior use of pyrotinib.
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 |
|---|---|---|
| PyrotinibPyrotinib as interventions were used in patients with HER2-positive advanced colorectal cancer | Drug | Single drug group |
| Pyrotinib in combination with trastuzumabPyrotinib in combination with trastuzumab as interventions were used in patients with HER2-positive advanced colorectal cancer | Drug | Dual-targeted drug group |
Primary outcome
Objective Response Rate
Time frame: Approximately 24 months
The proportion of patients with complete response or partial response according to RECIST v1.1.
5 secondary outcomes
Disease Control Rate
Time frame: Approximately 24 months
Progression-Free Survival
Time frame: Up to 2 years
Overall Survival
Time frame: Up to 2 years
Duration of Response
Time frame: Approximately 24 months
The Incidence of Adverse Events
Time frame: From the first drug administration to within 28 days for the last treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: Undecided. The data were Shared with the sub-center, and the preliminary efficacy results were to be submitted to the tumor conference
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pyrotinib and Pyrotinib in combination with trastuzumab in people with Colorectal Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 12 inclusion and 5 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 15 Jul 2021. 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 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 Ying Yuan, Doctor (+86 13858193601, yuany@z2hospital.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: Approximately 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 15 Jul 2021.