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

NCT04380012 | Unknown Phase 2 DMC

• 1 other identifier: IR2019001210
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer

Keywords

HER2; Advanced Colorectal Cancer; Pyrotinib

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The proportion of patients with complete response or partial response according to RECIST v1.1.

  Approximately 24 months

Secondary Outcomes (5)

• Disease Control Rate

  Approximately 24 months

• Progression-Free Survival

  Up to 2 years

• Overall Survival

  Up to 2 years

• Duration of Response

  Approximately 24 months

• The Incidence of Adverse Events

  From the first drug administration to within 28 days for the last treatment

Study Arms (2)

Single drug group

EXPERIMENTAL

Pyrotinib: 400 mg, po, qd, 21d for a treatment cycle

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

Drug: Pyrotinib in combination with trastuzumab

Interventions

Pyrotinib DRUG

Pyrotinib as interventions were used in patients with HER2-positive advanced colorectal cancer

Single drug group

Pyrotinib in combination with trastuzumab DRUG

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

Dual-targeted drug group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Aged 18-75 years, male or female;
• \. ECOG performance status 0-2;
• \. Recurrent/metastatic advanced colorectal cancer diagnosed by histology or cytology;
• \. Patients who progressed on or were intolerable to standard therapy, or those who refused chemotherapy;
• \. At least one measurable lesion according to RECIST v1.1;
• \. 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;
• 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%;
• lead electrocardiogram: The QT interval corrected by the Fridericia method (QTcF) \< 470 msec;
• \. Sign the informed consent and agree to collect the clinical efficacy and information of the patient.

You may not qualify if:

• \. 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;
• \. History of substance abuse and cannot be cured or with mental disorders;
• \. Pregnant or lactating women; patients with fertility who are unwilling or unable to use effective contraception;
• \. Severe concomitant disease, or unsuitable to participate in this study decided by the investigator.
• \. Prior use of pyrotinib.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Zhejiang Cancer Hospital: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• Sir Run Run Shaw Hospital: collaborator

Study Sites (1)

The Second Affiliated hospital of Zhejiang University School of Medical

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

pyrotinib; Trastuzumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Ying Yuan, Doctor

CONTACT

+86 13858193601; yuany@z2hospital.com

XianHua Fu, Doctor

CONTACT

+86 15258222675; fxh198501@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: May 8, 2020
• Study Start: December 17, 2019
• Primary Completion: December 17, 2021
• Study Completion: June 17, 2022
• Last Updated: July 15, 2021

Record last verified: 2021-02

Locations

CN (1)