Clinical trial · Interventional
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
NCT04615312CI-TRIAL-00053441unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive System Tumors | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| a CDK4 / 6 inhibitor and a MEK inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- a CDK4 / 6 inhibitor and a MEK inhibitor
- description
- Participants will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment
- interventionNames
- Drug: a CDK4 / 6 inhibitor and a MEK inhibitor
Primary outcomes (1)
- measure
- To determine the maximum tolerated dose of a CDK4 / 6 inhibitor and a MEK inhibitor therapy
- timeFrame
- Up to approximately 24 months
Secondary outcomes (1)
- measure
- ORR
- timeFrame
- Up to approximately 24 months
- description
- the Objective Remission Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.