Phase I Clinical Study on the Safety and Tolerability of a CDK4 / 6 Inhibitor and a MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors

Henan Cancer Hospital1 site in 1 country50 target enrollmentNovember 14, 2020

ConditionsDigestive System Tumors

Interventionsa CDK4 / 6 inhibitor and a MEK inhibitor

Drugsa CDK4 / 6 inhibitor and a MEK inhibitor

Overview

Phase: Phase 1
Intervention: a CDK4 / 6 inhibitor and a MEK inhibitor
Conditions: Digestive System Tumors
Sponsor: Henan Cancer Hospital
Enrollment: 50
Locations: 1
Primary Endpoint: To determine the maximum tolerated dose of a CDK4 / 6 inhibitor and a MEK inhibitor therapy
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, open, phase I clinical study to evaluate the safety and tolerability of a CDK4 / 6 inhibitor and a MEK inhibitor in the treatment of metastatic digestive system tumors

Registry

clinicaltrials.gov

Start Date

November 14, 2020

End Date

August 30, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Henan Cancer Hospital

Responsible Party

Principal Investigator

LiNing

Chief Physician

Henan Cancer Hospital

Eligibility Criteria

Inclusion Criteria

•Aged 18-75 years;
•ECOG score ≤ 1;
•Patients with advanced KRAS mutation or metastatic digestive system tumor confirmed by histology or cytology and imaging diagnosis;
•According to Recist1.1, there was at least one measurable lesion;
•The expected survival time was more than 12 weeks;

Exclusion Criteria

•Patients who received any anti-tumor treatment within 4 weeks before enrollment, including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, or participated in another intervention clinical trial;
•Previous treatment with targeted BRAF, MEK, ERK or CDK family related inhibitors;
•The third space effusion (such as massive pleural effusion or ascites) with clinical symptoms that cannot be controlled by drainage or other methods;
•Allergy to any test drug and its excipients, or serious allergic history, or contraindication of the test drug;
•Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;