A Trail of CDK4 / 6 Inhibitor and MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors
Primary Purpose
Digestive System Tumors
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
a CDK4 / 6 inhibitor and a MEK inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Digestive System Tumors
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;
Sites / Locations
- Henan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
a CDK4 / 6 inhibitor and a MEK inhibitor
Arm Description
Participants will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment
Outcomes
Primary Outcome Measures
To determine the maximum tolerated dose of a CDK4 / 6 inhibitor and a MEK inhibitor therapy
Secondary Outcome Measures
ORR
the Objective Remission Rate
Full Information
NCT ID
NCT04615312
First Posted
October 29, 2020
Last Updated
August 20, 2021
Sponsor
Henan Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04615312
Brief Title
A Trail of CDK4 / 6 Inhibitor and MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 14, 2020 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive System Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
a CDK4 / 6 inhibitor and a MEK inhibitor
Arm Type
Experimental
Arm Description
Participants will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment
Intervention Type
Drug
Intervention Name(s)
a CDK4 / 6 inhibitor and a MEK inhibitor
Intervention Description
Participant will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment to determine the maximum tolerated dose
Primary Outcome Measure Information:
Title
To determine the maximum tolerated dose of a CDK4 / 6 inhibitor and a MEK inhibitor therapy
Time Frame
Up to approximately 24 months
Secondary Outcome Measure Information:
Title
ORR
Description
the Objective Remission Rate
Time Frame
Up to approximately 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Li, PhD
Phone
13526501903
Email
lining97@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ning Li, PhD
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suxia Luo, PhD
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Li, PhD
Phone
0086-13526501903
Email
lining97@126.com
First Name & Middle Initial & Last Name & Degree
Ning Li, PhD
First Name & Middle Initial & Last Name & Degree
Suxia Luo, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Trail of CDK4 / 6 Inhibitor and MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors
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