NCT02378389

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 or Pyrotinib in combination with Docetaxel in patients with HER2 positive advanced gastric cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2014

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 4, 2015

Status Verified

February 1, 2015

Enrollment Period

1.9 years

First QC Date

February 11, 2015

Last Update Submit

February 27, 2015

Conditions

HER2 Positive Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • The maximum-tolerated dose (MTD) of Pyrotinib and that of Pyrotinib with Docetaxel in patients with HER2 positive advanced gastric cancer

    MTD will be defined as the maximum dose level at which no more than one subject out of three experience has a dose-limiting toxicity (DLT) upon completing one treatment cycle. DLT was defined as the certain AEs which were observed during the first cycle (D1-D21) of treatment

    21 days

Secondary Outcomes (7)

  • Cmax of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer

    12 months

  • Tmax of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer

    12 months

  • T1/2 of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer

    12 months

  • AUCss of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer

    12 months

  • R of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer

    12 months

  • +2 more secondary outcomes

Study Arms (1)

Pyrotinib/Pyrotinib with Docetaxel

EXPERIMENTAL

Subjects would be treated with Pyrotinib (Part 1) or Pyrotinib with Docetaxel (Part 2). A subject is only allowed to participant in one part of this trial.

Drug: Pyrotinib/Pyrotinib with Docetaxel

Interventions

Pyrotinib/Pyrotinib with DocetaxelDRUG

Pyrotinib oral daily, 240 mg, 320 mg, 400 mg.... Docetaxel i.v. once every 21 days.

Pyrotinib/Pyrotinib with Docetaxel

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 advanced gastric cancer (including adenocarcinoma of esophageal-gastric junction), with clinical phase III/IV.
  • No severe impairment of liver and kidney function, required laboratory values including following parameters:ANC:≥1.5x109/L, Platelet count:≥90x109/L, Hemoglobin:≥9.0 g/dL, Total bilirubin:≤1xULN, ALT and AST: ≤1.5xULN (for patients with liver metastases,ALT and AST:≤5xULN), ALP:≤2.5xULN, BUN and creatine:≤1xULN, creatine clearance rate:≥50 mL/min, LVEF:≥50%, QTcF:\<450 ms (male), \<470 ms (female),INR:≤1.5xULN, APTT:≤1.5xULN.
  • Signed informed consent.
  • For subjects treated by Pyrotinib only:
  • \- Failed or intolerable of prior therapies.
  • For subjects treated by Pyrotinib with Docetaxel:
  • \- Failed or intolerable of prior therapies, no previous treatment of taxane, no previous treatment of HER2 targeted inhibitors.

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.
  • Steroid treatment for more than 50 days, or in need of long-term use of steroids.
  • 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.
  • Less than 4 weeks from the last clinical trial or adverse events of previous trials (not including alopecia or asthenia).
  • Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
  • Subjects who can not interrupt using of the drugs causing QT prolongation during study.
  • Subjects with intracranial lesions (by MRI or CT).
  • Subjects suffered from other malignancies during last 5 years, not including cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma.
  • Subjects with bone or skin as the only target lesion.
  • Receiving any other antitumor therapy.
  • Known history of hypersensitivity to any of the components or metabolites of the investigational drugs or to Tween-80.
  • Subjects with clear tendency of gastointestinal bleeding. Including the following: subjects with local active ulcer lesions and fecal occult blood (++) are excluded; subjects with less than 2 months from the last history of black stools or haematemesis are excluded; for subjects with fecal occult blood (+) and primary lesion not resected, endoscopy is required,if gastric ulcer is found and the principal investigator of the site consider possible occurence of gastointestinal bleeding, the subject should be excluded.
  • Ongoing infection or peripheral neuropathy (determined by investigator).
  • History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beijing Cancer Hospital, Peking University

Beijing, Beijing Municipality, 100037, China

RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Cancer center, Sun Yet-sen University

Guangzhou, Guangdong, China

RECRUITING

Related Publications (2)

  • Liu D, Kou F, Gong J, Wang Z, Zhang X, Li J, Li Y, Li J, Zhou J, Lu M, Wang X, Lu Z, Cao Y, Zou J, Zhu X, Xu R, Shen L. Pyrotinib alone or in combination with docetaxel in refractory HER2-positive gastric cancer: A dose-escalation phase I study. Cancer Med. 2023 May;12(9):10704-10714. doi: 10.1002/cam4.5830. Epub 2023 Apr 20.

    PMID: 37081722DERIVED

  • Chen Z, Xu Y, Gong J, Kou F, Zhang M, Tian T, Zhang X, Zhang C, Li J, Li Z, Lai Y, Zou J, Zhu X, Gao J, Shen L. Pyrotinib combined with CDK4/6 inhibitor in HER2-positive metastatic gastric cancer: A promising strategy from AVATAR mouse to patients. Clin Transl Med. 2020 Aug;10(4):e148. doi: 10.1002/ctm2.148.

    PMID: 32898333DERIVED

MeSH Terms

Interventions

pyrotinibDocetaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Central Study Contacts

Qing Yang, MD

CONTACT

157 0515 5017yangqing@hrs.com.cn

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

February 11, 2015

First Posted

March 4, 2015

Study Start

September 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2017

Last Updated

March 4, 2015

Record last verified: 2015-02

Locations

CN(4)