A Clinical Study of Pyrotinib in Patients With HER2-positive Advanced Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Pyrotinib Maleate With or Without Trastuzumab in the Treatment of HER2-positive Advanced Colorectal Cancer: a Multicenter Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04380012
• Other study ID #: IR2019001210
• Status: Recruiting
• Phase: Phase 2
• Start date: December 17, 2019
• Est. completion date: June 17, 2022

Study information

• Verified date: February 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Ying Yuan, Doctor
• Phone: +86 13858193601
• Email: yuany[@]z2hospital.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To Observe the Efficacy and Safety of Pyrotinib Maleate in Patients With HER2-positive Advanced Colorectal Cancer

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 17, 2022
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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;

• 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):

1. Blood routine: neutrophils (ANC) = 1.5 × 10^9 / L; platelet count (PLT) = 90 × 10^9 / L; hemoglobin (Hb) = 90 g / L;

2. 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);

3. Cardiac color doppler ultrasound: left ventricular ejection fraction (LVEF) = 55%;

4. 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Pyrotinib
Pyrotinib as interventions were used in patients with HER2-positive advanced colorectal cancer
• Pyrotinib in combination with trastuzumab
Pyrotinib in combination with trastuzumab as interventions were used in patients with HER2-positive advanced colorectal cancer

Locations

Country	Name	City	State
China	The Second Affiliated hospital of Zhejiang University School of Medical	Hangzhou	Zhejiang

Sponsors (5)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	First Affiliated Hospital of Zhejiang University, Sir Run Run Shaw Hospital, Zhejiang Cancer Hospital, Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	The proportion of patients with complete response or partial response according to RECIST v1.1.	Approximately 24 months
Secondary	Disease Control Rate	The proportion of patients with complete response, partial response or stable disease according to RECIST v1.1.	Approximately 24 months
Secondary	Progression-Free Survival	Time from the initiation of treatment to disease progression or any-cause death.	Up to 2 years
Secondary	Overall Survival	Time from the initiation of treatment to any-cause death.	Up to 2 years
Secondary	Duration of Response	Time from complete response or partial response to disease progression or any-cause death.	Approximately 24 months
Secondary	The Incidence of Adverse Events	Adverse Events and Serious Adverse Events were graded according to the NCI-CTCAE V5.0.	From the first drug administration to within 28 days for the last treatment