A Trail of CDK4 / 6 Inhibitor and MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors
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
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedStudy Start
First participant enrolled
November 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedAugust 23, 2021
August 1, 2021
10 months
October 29, 2020
August 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the maximum tolerated dose of a CDK4 / 6 inhibitor and a MEK inhibitor therapy
Up to approximately 24 months
Secondary Outcomes (1)
ORR
Up to approximately 24 months
Study Arms (1)
a CDK4 / 6 inhibitor and a MEK inhibitor
EXPERIMENTALParticipants will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment
Interventions
Participant will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment to determine the maximum tolerated dose
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Study Officials
- PRINCIPAL INVESTIGATOR
Ning Li, PhD
Henan Cancer Hospital
- PRINCIPAL INVESTIGATOR
Suxia Luo, PhD
Henan Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
October 29, 2020
First Posted
November 4, 2020
Study Start
November 14, 2020
Primary Completion
August 30, 2021
Study Completion
August 30, 2022
Last Updated
August 23, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share