Efficacy and Safety of Pyrotinib in HER2 Positive Gastrointestinal Tumors

NCT ID: NCT04960943

Last Updated: 2021-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2023-03-01

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.

Detailed Description

This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive gastrointestinal tumors. Three cohorts were designed for this trial. Cohort 1: patients with gastric cancer or esophageal adenocarcinoma receiving paclitaxel combined with pyrotinib for second-line therapy; Cohort 2: patients with gastric cancer or esophageal adenocarcinoma receiving pyrotinib monotherapy for third-line or posterior line therapy; Cohort 3: patients with colorectal cancer receiving pyrotinib combined with/without trastuzumab for third-line or posterior line therapy.

Conditions

Gastrointestinal Tumor; Effect of Drug

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pyrotinib

Pyrotinib with or without paclitaxel/trastuzumab treatment

Group Type: EXPERIMENTAL

Pyrotinib with or without trastuzumab

Intervention Type: 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.

Interventions

Pyrotinib with or without trastuzumab

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.

Intervention Type: DRUG

Other Intervention Names

pyrotinib with other drugs

Eligibility Criteria

Inclusion Criteria

1. Aged ≥18

2. ECOG performance status of 0 to 1.

3. Life expectancy of more than 12 weeks.

4. At least one measurable lesion exists.(RECIST 1.1) Histologically or cytologic confirmed HER2 positive gastrointestinal tumors who failed prior therapies.

5. 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

6. Signed informed consent.

Exclusion Criteria

1. Subjects with third space fluid that can not be controled by drainage or other methods.

2. Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.

3. Less than 4 weeks from the last radiotherapy, chemotherapy, target therapy

4. 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.

5. Receiving any other antitumor therapy.

6. Known history of hypersensitivity to pyrotinib or any of it components. Ongoing infection (determined by investigator).

7. History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.

8. 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.

9. Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.

10. Known history of neurological or psychiatric disease, including epilepsy or dementia.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xiaodong Zhu

MD,PhD, Fudan University Shanghai Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaodong Zhu, phD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaodong Xiaodong, phD

Role: CONTACT

xddr001@163.com

8621-64175590

Facility Contacts

Wenhua Li

Role: primary

References

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.

Reference Type: DERIVED

PMID: 35941028 (View on PubMed)

Other Identifiers

FUSCC-HER2-G

Identifier Type: -

Identifier Source: org_study_id