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
Verified date | August 2021 |
Source | Henan Cancer Hospital |
Contact | Ning Li, PhD |
Phone | 13526501903 |
lining97[@]126.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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; |
Country | Name | City | State |
---|---|---|---|
China | Henan Cancer Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Henan Cancer Hospital |
China,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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