Combining targeted therapies for solid tumors using CDK4/6 inhibitors and anti-VEGF agents
Precision Therapy for Solid Tumors: Synergistic Inhibition of Cell Proliferation and Angiogenesis Via CDK4/6 and Anti-VEGF Approach Targeting LncRNA Expression
This study is testing if combining two cancer treatments, Palbociclib and Bevacizumab, can help people with solid tumors like colorectal, breast, and ovarian cancers feel better and respond better to treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lebanese University Academic / other |
| Drugs / interventions | Bevacizumab, chemotherapy |
| Locations | 2 sites (Tripoli, North Lebanon and 1 other locations) |
| Trial ID | NCT06307249 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the combined effects of Palbociclib, a CDK4/6 inhibitor, and Bevacizumab, an anti-VEGF agent, on patients with solid tumors, including colorectal, breast, and ovarian cancers. The study aims to explore the potential synergistic benefits of these therapies while also examining Long Non-Coding RNAs (LncRNAs) as biomarkers for treatment response. Patients will be stratified based on genetic risk factors, allowing for a precision medicine approach. The trial begins with colorectal cancer and plans to expand to other solid tumors, focusing on both efficacy and safety.
Who should consider this trial
Good fit: Ideal candidates include individuals over 18 years old with stage III or IV colorectal, breast, lung, or ovarian cancer.
Not a fit: Patients with a history of hematological cancers, autoimmune diseases, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with solid tumors.
How similar studies have performed: While the combination of CDK4/6 inhibitors and anti-VEGF agents is a novel approach, similar studies have shown promise in targeting solid tumors with dual therapies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tripoli, North Lebanon and 1 other locations
- Haykel Hospital — Tripoli, North Lebanon, Lebanon (Recruiting)
- Lebanese University — Tripoli, North Lebanon, Lebanon (Recruiting)
Study contacts
- Study coordinator: Nehman Makdissy, Professor
- Email: nehman.makdissy@ul.edu.lb
- Phone: 71210250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.