Study Evaluating Pyrotinib in Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer

NCT02361112 | Completed Phase 1

• 1 other identifier: BLTN-Ic
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib in combination with capecitabine in patients with HER2 positive metastatic breast cancer: To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD) To determine the dose-limiting toxicity (DLT) To determine the pharmacokinetic profile of Pyrotinib To assess preliminary antitumor activity To determine preliminary regimen dose for phase II study

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one subject out of three experiences has a dose-limiting toxicity (DLT) upon completing one treatment cycle.

  DLT was difined as the cetain AEs which were observed during the first cycle (D1-D21）of treatment.

  21 days

Secondary Outcomes (3)

• Cmax, Tmax, T1/2, AUCss and R of pyrotinib and capecitabine in combination

  12 months

• the number of participants with adverse event

  12 months

• preliminary antitumor activity for the regimen, objective response rate

  12 months

Study Arms (1)

pyrotinib combined with capecitabine

EXPERIMENTAL

Drug: pyrotinib combined with capecitabine

Interventions

pyrotinib combined with capecitabine DRUG

pyrotinib combined with capecitabine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 and ≤70 years.
• 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 metastatic breast cancer which failed prior therapies.
• No previous treatment of capecitabin during the past 1 year.
• Required laboratory values including following parameters:
• ANC: ≥ 1.5 x 109/L Platelet count: ≥ 100 x 109/L Hemoglobin: ≥ 9.0 g/dL 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.
• Steroid treatment for more than 50 days, or in need of long-term use of steroids.
• Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
• Less than 4 weeks from the last radiotherapy,chemotherapy，surgery，hermone treatment,target therapy, or less than 6 weeks from the nitrosoureas or mitomycin chemotherapy.
• Subjects with no efficacy during the previous treatment of capecitabine.
• 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.
• Subjects with intracranial lesions.
• Subjects with bone or skin as the only target lesion
• Treated or treating with HER2 tyrosine kinase inhibitors (TKIs) before study entry.
• Receiving any other antitumor therapy.
• Less than 4 weeks from the last clinical trial.
• Known history of hypersensitivity to pyrotinib、capecitabine or any of its components or metabolites.
• Ongoing infection (determined by investigator).
• History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (2)

• Guan X, Ma F, Li Q, Chen S, Lan B, Fan Y, Wang J, Luo Y, Cai R, Zhang P, Li Q, Xu B. Survival benefit and biomarker analysis of pyrotinib or pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer: a pooled analysis of two phase I studies. Biomark Res. 2023 Feb 20;11(1):21. doi: 10.1186/s40364-023-00453-0.

  PMID: 36803645 DERIVED

• Li Q, Guan X, Chen S, Yi Z, Lan B, Xing P, Fan Y, Wang J, Luo Y, Yuan P, Cai R, Zhang P, Li Q, Zhong D, Zhang Y, Zou J, Zhu X, Ma F, Xu B. Safety, Efficacy, and Biomarker Analysis of Pyrotinib in Combination with Capecitabine in HER2-Positive Metastatic Breast Cancer Patients: A Phase I Clinical Trial. Clin Cancer Res. 2019 Sep 1;25(17):5212-5220. doi: 10.1158/1078-0432.CCR-18-4173. Epub 2019 May 28.

  PMID: 31138588 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: February 11, 2015
• Study Start: August 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 9, 2018

Record last verified: 2018-07

Locations

CN (1)