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Efficacy and Safety of Pyrotinib in HER2 Positive Gastrointestinal Tumors

Primary Purpose

Gastrointestinal Tumor, Effect of Drug

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Pyrotinib with or without trastuzumab

About this trial

This is an interventional treatment trial for Gastrointestinal Tumor focused on measuring pyrotnib, HER2, Gastrointestinal Tumor, Phase II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pyrotinib

Arm Description

Pyrotinib with or without paclitaxel/trastuzumab treatment

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

evaluated in the 24th month since the treatment began

Secondary Outcome Measures

Progression Free Survival (PFS)

evaluated in the 24th month since the treatment began

Full Information

NCT ID

NCT04960943

First Posted

July 9, 2021

Last Updated

July 9, 2021

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT04960943

Brief Title

Efficacy and Safety of Pyrotinib in HER2 Positive Gastrointestinal Tumors

Official Title

Efficacy and Safety of Pyrotinib in Patients With HER2 Positive Refractory or Metastatic Gastrointestinal Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2020 (Actual)

Primary Completion Date

September 9, 2022 (Anticipated)

Study Completion Date

March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Tumor, Effect of Drug

Keywords

pyrotnib, HER2, Gastrointestinal Tumor, Phase II

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pyrotinib

Arm Type

Experimental

Arm Description

Pyrotinib with or without paclitaxel/trastuzumab treatment

Intervention Type

Drug

Intervention Name(s)

Pyrotinib with or without trastuzumab

Other Intervention Name(s)

pyrotinib with other drugs

Intervention Description

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.

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

evaluated in the 24th month since the treatment began

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

evaluated in the 24th month since the treatment began

Time Frame

24 months

Other Pre-specified Outcome Measures:

Title

overall survival(OS)

Description

evaluated in the 24th month since the treatment began

Time Frame

24 months

Title

time to progression (TTP)

Description

time to progression since the treatment began

Time Frame

24 months

Title

duration of response (DoR)

Description

the time of duration of response

Time Frame

24 months

Title

disease control rate (DCR)

Description

the proportion of patients who had a best response

Time Frame

24 months

Title

Safety and Tolerability

Description

Number of Participants with treatment related Adverse Events as Assessed by CTCAE v5.0

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaodong Xiaodong, phD

Phone

8621-64175590

xddr001@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaodong Zhu, phD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenhua Li

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35941028

Citation

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.

Results Reference

derived

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Efficacy and Safety of Pyrotinib in HER2 Positive Gastrointestinal Tumors

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