RecruitingPhase 1NCT06307249

Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA

Precision Therapy for Solid Tumors: Synergistic Inhibition of Cell Proliferation and Angiogenesis Via CDK4/6 and Anti-VEGF Approach Targeting LncRNA Expression


Sponsor

Lebanese University

Enrollment

50 participants

Start Date

Feb 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Solid tumors pose significant challenges in current therapeutic approaches. Targeted therapy has emerged as a promising avenue, aiming to enhance treatment efficacy while minimizing adverse effects. This clinical trial focuses on an innovative combination of two targeted inhibitors, Palbociclib and Bevacizumab, for their potential synergistic effects in addressing these challenging malignancies. Moreover, this study incorporates a molecular approach by considering Long Non-Coding RNAs (LncRNAs) as biomarkers. Initiating with a focus on colorectal cancer, the study aims to expand its scope to other solid tumors, including lung, breast, ovarian and other cancers. Palbociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, disrupts the cell cycle progression, particularly in cancer cells with specific molecular characteristics. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, targets angiogenesis-a critical process for tumor growth and metastasis. The rationale behind combining these agents lies in their complementary mechanisms of action, potentially leading to enhanced antitumor effects. LncRNAs have shown promise in predicting treatment response and prognosis in various cancers, providing an additional layer of precision to the treatment strategy. By elucidating the molecular basis through LncRNA analysis, the trial aims to tailor the treatment to the specific molecular profile of each patient, ultimately striving for better outcomes and improved survival rates. This novel combination therapy, coupled with a personalized biomarker-driven approach, represents a cutting-edge strategy in the pursuit of more effective and individualized treatment for solid tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a precision medicine combination — a CDK4/6 inhibitor (a drug that blocks cancer cell growth) combined with an anti-VEGF drug (which cuts off the blood supply to tumors) — targeting a specific genetic pathway in advanced solid tumors. **You may be eligible if...** - You are over 18 years old and of white ethnicity - You have been diagnosed with colorectal cancer, lung cancer, genitourinary cancer, or breast cancer at stage III or IV - Your cancer has spread (with or without lymph node involvement) - You have no personal history of blood cancers or prior cancers **You may NOT be eligible if...** - You have or have had a blood cancer (leukemia, lymphoma, etc.) - You have inflammatory bowel disease - You have pre-existing cardiovascular disease or coronary artery disease - You have autoimmune disease, diabetes, or hypertension - You have neurological diseases or damage to the heart, kidneys, bones, or brain from cancer - You have more than one type of cancer at the same time Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICSNP

Diagnostics of patients' carriers or not of the risk allele(s)

DRUGPalbociclib 125mg

Palbociclib 125mg/day/os over 21 days every 28 days

DRUGBevacizumab

10mg/kg every 21 days


Locations(2)

Haykel Hospital

Tripoli, North Lebanon, Lebanon

Lebanese University

Tripoli, North Lebanon, Lebanon

View Full Details on ClinicalTrials.gov

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NCT06307249


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