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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-14

Study Completion Date

2022-08-30

Brief Summary

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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

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Detailed Description

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Conditions

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Digestive System Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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a CDK4 / 6 inhibitor and a MEK inhibitor

Participants will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment

Group Type EXPERIMENTAL

a CDK4 / 6 inhibitor and a MEK inhibitor

Intervention Type DRUG

Participant will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment to determine the maximum tolerated dose

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No