Efficacy and Safety of Pyrotinib in HER2 Positive Gastrointestinal Tumors

NCT04960943 | Unknown Phase 2

• 1 other identifier: FUSCC-HER2-G
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Targeting human epidermal factor receptor 2 (HER2) therapy have shown the anti-tumor efficacy in patients with HER2-positive gastrointestinal tumors. Pyrotinib is an irreversible small-molecule receptor tyrosine kinase inhibitor targeting both epidermal growth factor receptor (EGFR) and HER2. This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive gastrointestinal tumors.

Conditions

Gastrointestinal Tumor; Effect of Drug

Keywords

pyrotnib, HER2, Gastrointestinal Tumor, Phase II

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  evaluated in the 24th month since the treatment began

  24 months

Secondary Outcomes (1)

• Progression Free Survival (PFS)

  24 months

Other Outcomes (5)

• overall survival(OS)

  24 months

• time to progression (TTP)

  24 months

• duration of response (DoR)

  24 months

Study Arms (1)

Pyrotinib

EXPERIMENTAL

Pyrotinib with or without paclitaxel/trastuzumab treatment

Drug: Pyrotinib with or without trastuzumab

Interventions

Pyrotinib with or without trastuzumab DRUG

After enrollment, patients of all the three cohorts were given 400 mg/d oral pyrotinib continuously, every 21 days as a cycle; Cohort 1 and 2 : Patients with gastric cancer or esophageal adenocarcinoma were combined with paclitaxel 80 mg/m2, intravenously, once on the first and eighth day. Cohort 3: Patients with colorectal cancer were given trastuzumab at an initial load dose of 8 mg/kg followed by 6 mg/kg every 3 weeks.

Also known as: pyrotinib with other drugs

Pyrotinib

Eligibility Criteria

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

You may qualify if:

• Aged ≥18
• ECOG performance status of 0 to 1.
• Life expectancy of more than 12 weeks.
• At least one measurable lesion exists.(RECIST 1.1) Histologically or cytologic confirmed HER2 positive gastrointestinal tumors who failed prior therapies.
• Required laboratory values including following parameters:
• ANC: ≥ 1.5 x 10\^9/L, Platelet count: ≥ 80 x 10\^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: \< 470 ms
• Signed informed consent.

You may not qualify if:

• Subjects with third space fluid that can not be controled by drainage or other methods.
• Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
• Less than 4 weeks from the last radiotherapy, chemotherapy, target therapy
• Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry. Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
• Receiving any other antitumor therapy.
• Known history of hypersensitivity to pyrotinib or any of it components. Ongoing infection (determined by investigator).
• History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
• Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
• Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
• Known history of neurological or psychiatric disease, including epilepsy or dementia.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• Chang J, Xu M, Wang C, Huang D, Zhang Z, Chen Z, Zhu X, Li W. Dual HER2 Targeted Therapy With Pyrotinib and Trastuzumab in Refractory HER2 Positive Metastatic Colorectal Cancer: A Result From HER2-FUSCC-G Study. Clin Colorectal Cancer. 2022 Dec;21(4):347-353. doi: 10.1016/j.clcc.2022.07.003. Epub 2022 Jul 16.

  PMID: 35941028 DERIVED

MeSH Terms

Conditions

Digestive System Neoplasms

Interventions

pyrotinib; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Xiaodong Zhu, phD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaodong Xiaodong, phD

CONTACT

8621-64175590; xddr001@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 14, 2021
• Study Start: February 1, 2020
• Primary Completion: September 9, 2022
• Study Completion: March 1, 2023
• Last Updated: July 14, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)