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

Digestive System Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04615312
• Other study ID #: CRC-PANC-IIT-SHR6390-SHR7390
• Status: Recruiting
• Phase: Phase 1
• Start date: November 14, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: August 2021
• Source: Henan Cancer Hospital
• Contact: Ning Li, PhD
• Phone: 13526501903
• Email: lining97[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Digestive System Tumors
• Gastrointestinal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose of a CDK4 / 6 inhibitor and a MEK inhibitor therapy		Up to approximately 24 months
Secondary	ORR	the Objective Remission Rate	Up to approximately 24 months