NCT04227041

Brief Summary

To evaluate the efficacy and safety of pyrotinib combined with capecitabine in patients with metastatic her-2 positive colorectal cancer after standard treatment.

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
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 10, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

January 10, 2020

Last Update Submit

January 12, 2020

Conditions

HER-2 Positive Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

  • Maximally Tolerated Dose (MTD)

    Evaluation of tumor burden based on RECIST criteria.

    up to 36 months

  • Progression-free survival (PFS)

    Evaluation of tumor burden based on RECIST criteria.

    up to 36 months

Secondary Outcomes (4)

  • Objective Response Rate (ORR)

    up to 36 months

  • Duration Of Response (DOR)

    up to 36 months

  • Disease Control Rate (DCR)

    up to 36 months

  • Incidence of Treatment-Emergent Adverse Events [Safety]

    up to 36 months

Study Arms (1)

HER2 positive metastatic colorectal cancer

EXPERIMENTAL
Drug: Pyrotinib in combination with capecitabine

Interventions

Pyrotinib in combination with capecitabineDRUG

Pyrotinib in combination with capecitabine

Also known as: Capecitabine
HER2 positive metastatic colorectal cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients should be histologically diagnosed with metastatic CRC and after receiving at least two standard treatment regimens；
  • Patients with HER2 positive；
  • Metastatic colorectal cancer (stage Ⅳ, T1-4N0-2M1)；
  • Life expectancy is at least 6 months
  • ECOG score 0-1；
  • The functional level of the major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocytes or platelets)：

You may not qualify if:

  • The histopathological type is mucinous adenocarcinoma or ovarian implant metastasis；
  • Patients who have previously been treated with anti-Her2-targeted drugs；
  • Patients with surgical opportunity or potential for surgical treatment；
  • Patients with a high risk of bleeding or perforation due to a tumor that has apparently invaded adjacent organs (including large vessels) of the colorectal lesion or who have developed fistulas；
  • Patients with any severe and/or uncontrolled disease;
  • Patients with any or present brain metastases；
  • Women who were pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qingdao University Hospital

Qingdao, Shandong, China

Location

MeSH Terms

Interventions

pyrotinibCapecitabine

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Tao Jiang, Dr.

CONTACT

18661806663jiangtao111@sina.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2020

First Posted

January 13, 2020

Study Start

January 10, 2020

Primary Completion

January 10, 2021

Study Completion

January 10, 2023

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations

CN(1)