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Taking people in LebanonPhase 1

Tests palbociclib and bevacizumab together in people with solid tumors

Tests two cancer drugs together in adults with solid tumors, such as colorectal cancer.

Plain-language title generated from the registry record
Registry title: Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA

Key facts

Where
Tripoli, LebanonSee the 2 sites
Phase
Phase 1

Where in Lebanon

  • Haykel HospitalTripoli, LebanonTaking people
  • Lebanese UniversityTripoli, LebanonTaking people

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  2. Are travel costs paid?
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  4. What happens if I want to stop?
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Trial details

Who runs it
Lebanese University
Trial code
NCT06307249
Record updated
12 March 2024
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: 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; History of surgeries; Familial polyposis; Alcohol or smoking habits; Body mass index (BMI) >30; Significant weight loss within the last 2 years; Pregnancy; Related patients.

ClinicalTrials.gov NCT06307249