NCT06307249 Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA
| NCT ID | NCT06307249 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Lebanese University |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-02-15 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2023-02-15 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Individuals of white ethnicity. * Age between \> 18 * Both males and females. * Diagnosis of selected cancer type (e.g., colorectal cancer, lung cancer, genitourinary cancers, breast cancer). * Cancer stage III/ IV with or without metastasis or lymph node dissemination at the time of enrollment. * Unrelated patients. Exclusion Criteria: * History of hematological cancer types or previous cancers, recurrent or relapse. * Diagnosis of inflammatory bowel diseases. * Pre-existing cardiovascular diseases or coronary artery diseases. * Confirmed treated or untreated autoimmune diseases. * Metabolic disorders, diabetes, or hypertension. * Neurological diseases. * Evidence of cardiac, renal, bone, or cerebral damage. * Presence of more than one type of malignancies. * Active infections or myositis. * Familial polyposis. * Alcohol or smoking habits. * Body mass index (BMI) \>30. * Significant weight loss within the last 2 years. * History of surgeries. * Pregnancy. * Related patients.
Contact & Investigator
Nehman Makdissy, Professor
STUDY CHAIR
Lebanese University
Frequently Asked Questions
Who can join the NCT06307249 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06307249 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06307249 currently recruiting?
Yes, NCT06307249 is actively recruiting participants. Contact the research team at nehman.makdissy@ul.edu.lb for enrollment information.
Where is the NCT06307249 trial being conducted?
This trial is being conducted at Tripoli, Lebanon, Tripoli, Lebanon.
Who is sponsoring the NCT06307249 clinical trial?
NCT06307249 is sponsored by Lebanese University. The principal investigator is Nehman Makdissy, Professor at Lebanese University. The trial plans to enroll 50 participants.
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