Skip to content

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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039560
Enrollment
Unknown
Registered
2020-10-31
Start date
2020-10-30
Completion date
Unknown
Last updated
2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic digestive system tumors

Interventions

Experimental group:a CDK4 / 6 inhibitor and a MEK inhibitor

Sponsors

Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Objective remission rate;

Countries

China

Contacts

Public ContactSuxia Luo, Li Ning

Henan Cancer Hospital

lining97@126.com+86 13526501903

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026