A Trail of CDK4 / 6 Inhibitor and MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors

August 20, 2021 updated by: LiNing, Henan Cancer Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Suxia Luo, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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;
  2. Previous treatment with targeted BRAF, MEK, ERK or CDK family related inhibitors;
  3. The third space effusion (such as massive pleural effusion or ascites) with clinical symptoms that cannot be controlled by drainage or other methods;
  4. Allergy to any test drug and its excipients, or serious allergic history, or contraindication of the test drug;
  5. Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: a CDK4 / 6 inhibitor and a MEK inhibitor
Participants will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment
Drug: a CDK4 / 6 inhibitor and a MEK inhibitor
Participant will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment to determine the maximum tolerated dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the maximum tolerated dose of a CDK4 / 6 inhibitor and a MEK inhibitor therapy
Time Frame: Up to approximately 24 months
Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: Up to approximately 24 months
the Objective Remission Rate
Up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Investigators

  • Principal Investigator: Suxia Luo, PhD, Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2020

Primary Completion (Anticipated)

August 30, 2021

Study Completion (Anticipated)

August 30, 2022

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

October 29, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC-PANC-IIT-SHR6390-SHR7390

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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