Sign in

NCT06307249RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 12 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
50 (estimated)
First submitted
5 Feb 2024
Start date
15 Feb 2023
Primary completion date
31 Dec 2025
Lead sponsor
Lebanese University
NCT number
NCT06307249

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 50
  • From 15 Feb 2023 to the primary completion date, 31 Dec 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • Familial polyposis.
  • Alcohol or smoking habits.
  • Body mass index (BMI) \>30.
  • Significant weight loss within the last 2 years.
  • Pregnancy.
  • Related patients.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Haykel Hospital
Coordinator of this site? Confirm its status
TripoliLebanonRecruiting
Lebanese University
Coordinator of this site? Confirm its status
TripoliLebanonRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.