CancerPhase 1PTST_PALBEVANCT06307249
Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA
A Phase 1 study testing SNP, Palbociclib 125mg and Bevacizumab in people with Cancer and Solid Tumor, run by Lebanese University at 2 sites in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumor, Colorectal Cancer
- What is being tested?
- SNP, Palbociclib 125mg and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesLebanon
- Study dates
- 15 Feb 2023to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon2 sites, 2 recruiting
- Recruiting
Haykel Hospital
Tripoli, North Lebanon, 961
David Wehbe, MD, Wehbehdavid@hotmail.com
Malak Naboulsi, PharmD, malak.naboulsi@gmail.com
- Recruiting
Lebanese University
Tripoli, North Lebanon, 961
Neham Makdissy, Professor, 71210250 ext. +961, nehman.makdissy@ul.edu.lb
Samar Hamoui, PhD
About this study
Official title: 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.
Read the detailed description
This innovative clinical trial applies a comprehensive strategy to study the complex interplay of biomarkers, immune responses, angiogenesis, and proliferation in solid tumor progression. This approach integrates the selective cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, such as Palbociclib, with the angiogenesis inhibitor, like Bevacizumab. This dual-targeted therapy holds promise for treating various solid tumors, including colorectal cancer, breast cancer, lung cancer, ovarian cancer, and others.
A focal point of the study is the investigation of Long Non-Coding RNA (LncRNA) , chosen for its potential as a prognostic and predictive biomarker. LncRNA plays a multifaceted role in cellular processes, influencing cell cycle checkpoints, angiogenesis, and metastasis. Its aberrant expression across different cancers positions as a key subject of investigation, particularly considering its potential association with polymorphisms. Beyond its involvement in proliferation and angiogenesis. It also adds an additional layer of complexity, crucial for understanding patient outcomes.
The investigation initiates with colorectal cancer and extends to other solid cancers, including lung, ovarian, and breast cancers. Patients are stratified into carriers or non-carriers of the risk allele, forming the foundation for precision-driven treatments. The study design comprises two distinct groups within the colorectal cancer cohort, Group 1 and Group 2, involving patients with and without the risk allele. These groups undergo combined therapy with a CDK4/6 inhibitor and anti-VEGF. Similarly, the distribution is maintained for patients with and without the risk allele in other solid tumors (lung, breast, ovarian, etc.), receiving the same combined therapy tailored to their molecular profiles whether taken as 1st line of treatment or 2nd line of treatment.
Precise pre-treatment assessments establish baseline parameters, while post-treatment evaluations cover outcomes such as tumor progression, cancer regression, survival rates, and thromboembolic events. The interdependent relationship between proliferative tumor cells and angiogenesis, coupled with the potential impact of thromboembolism, is pivotal for cancer progression. Dysregulated cell cycle machinery, often involving overactive cyclin-dependent kinases (CDKs) like CDK4/6, drives uncontrolled proliferation, leading to a hypoxic microenvironment that triggers angiogenesis. Recognizing this symbiosis, the rationale for combining Palbociclib, a CDK4/6 inhibitor, with Bevacizumab, an anti-VEGF agent, becomes evident. While Palbociclib disrupts the cell cycle progression of proliferating tumor cells, hindering their uncontrolled growth, Bevacizumab concurrently targets the angiogenic process by inhibiting VEGF.
This dual-targeted approach aims to comprehensively address both the proliferative, angiogenic, and thromboembolic facets of tumor biology, potentially leading to a more effective and synergistic anti-tumor response.
Four groups will be considered:
Carrier Groups:
Group 1: "Carrier First-line Combined Therapy Group", C-FL-CT; Group 2: "Carrier Second-line Combined Therapy Group", C-SL-CT
Non-carrier Groups:
Group 3: "Non-carrier First-line Combined Therapy Group", NC-FL-CT; Group 4: "Non-carrier Second-line Combined Therapy Group", NC-SL-CT "Carrier"" denotes the patient who possesses the risk allele of the LncRNA CDKN2B-AS1.
Group 1: This group of patients, who are carriers of the risk alleles, will receive combined therapy as the initial first-line treatment without prior chemotherapy.
Group 2: This group of patients, who are carriers of the risk alleles, will receive combined therapy after having undergone prior chemotherapy, making it the second-line treatment.
Group 3: This group of patients, who are non-carriers of the risk alleles, will receive combined therapy as the initial first-line treatment without prior chemotherapy.
Group 4: This group of patients, who are non-carriers of the risk alleles, will receive combined therapy after having undergone prior chemotherapy, making it the second-line treatment.
In summary, the study integrates precision medicine, biomarker-driven therapies, and a comprehensive understanding of the molecular basis of tumor progression, including thromboembolism. This approach offers a promising avenue for the development of personalized and effective treatments for various solid tumors, emphasizing not only efficacy and safety but also the overall effectiveness of the proposed therapeutic interventions.
- Conditions
- Cancer, Solid Tumor, Colorectal Cancer, Breast Cancer, Ovarian Cancer, Lung Cancer
- Being tested
- SNP, Palbociclib 125mg, Bevacizumab
- Keywords
- LncRNA, Anti-VEGF, CDK4/6 inhibitor, Gene Polymorphism, Palbociclib, Bevacizumab, Inflammation, Immune Cells, Angiogenesis, Proliferative, Cancer
- Medical subject headings
- Neoplasms, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNPGenetic
Also called Risk Allele(s)
Diagnostics of patients' carriers or not of the risk allele(s)
Palbociclib 125mgDrug
Also called anti-CDK4/6
Palbociclib 125mg/day/os over 21 days every 28 days
BevacizumabDrug
Also called Anti-VEGF
10mg/kg every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Carrier First-line Combined Therapy Group C-FL-CT | Experimental | This group of patients, who are carriers of the risk alleles, will receive combined therapy as the initial first-line treatment without prior chemotherapy. Receives: Genetic: SNP; Drug: Palbociclib 125mg; Drug: Bevacizumab |
| Carrier Second-line Combined Therapy Group C-SL-CT | Experimental | This group of patients, who are carriers of the risk alleles, will receive combined therapy after having undergone prior chemotherapy, making it the second-line treatment. Receives: Genetic: SNP; Drug: Palbociclib 125mg; Drug: Bevacizumab |
| Non-carrier First-line Combined Therapy Group NC-FL-CT | Experimental | This group of patients, who are non-carriers of the risk alleles, will receive combined therapy as the initial first-line treatment without prior chemotherapy. Receives: Genetic: SNP; Drug: Palbociclib 125mg; Drug: Bevacizumab |
| Non-carrier Second-line Combined Therapy Group NC-SL-CT | Experimental | This group of patients, who are non-carriers of the risk alleles, will receive combined therapy after having undergone prior chemotherapy, making it the second-line treatment. Receives: Genetic: SNP; Drug: Palbociclib 125mg; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Cancer Progression
The assessment of cancer progression will be conducted using the standardized TNM staging system and applying the Response Evaluation Criteria (RECIST) guideline (ver. 1.1). Progression-Free Survival (PFS), a key primary clinical endpoint for assessing cancer progression, will be calculated as the duration (in months) from the date of enrollment in the study until the tumor progresses, new lesions appear, or until the participant's death from any cause based on RECIST guidelines, considering an increase in tumor size or the appearance of new lesions according to imaging assessments (e.g., CT, MRI, or PET scans) and clinical evaluations (including tumor markers and histopathological analysis).
Measured: [Time Frame: up to 60 months]
Identification of Potential Biomarkers
Finding and characterizing new biomarkers linked to thromboembolism and the advancement of cancer is the aim of this result. The evaluation will pay particular attention to Long Non-Coding RNAs (LncRNAs). At the time of study enrollment, biological samples (such as blood or tissue) from enrolled patients will be collected as part of the identification procedure. With Ct (Cycle threshold) serving as the standard unit of measurement for all genes, the evaluation will employ quantitative PCR (qPCR) to study and assess the expression and polymorphisms of the investigated genes. This thorough evaluation seeks to further our knowledge of the molecular markers and the course of cancer, shedding light on new pathways for diagnosis and treatment that might lead to better patient outcomes
Measured: [ Time Frame: Once at the moment of the patient's enrollment in the study]
Evaluation of Treatment Response to Palbociclib and Bevacizumab Combination Therapy
This main outcome evaluates the extent to which patients responding to combination therapy are managing both angiogenesis and the cancer cell cycle progression. The percentage change in tumor size, a measure of therapy efficacy, will be calculated using the RECIST criteria in the evaluation.
Measured: [ Time Frame: up to 60 months]
Secondary outcomes (5)
Survival Rates
Analysis of overall survival and progression-free survival rates among groups
Measured: [ Time Frame: up to 60 months]
Adverse Events
Monitoring and reporting of adverse events related to the Palbociclib and Bevacizumab treatment regimen.
Measured: [ Time Frame: up to 60 months]
Assessment of Immune Checkpoint Expression (e.g., PD-1 and CTLA-4)
The expression of immunological checkpoint molecules, namely cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and programmed cell death protein 1 (PD-1) is the main emphasis of this result. The goal is to comprehend how immunological checkpoints control the immune response. PCR or flow cytometry will be used to determine immunological checkpoint expression as part of the evaluation. The percentage of change in PD-1 and CTLA-4 expression levels throughout a 60-month period in comparison to their levels at the diagnostic time will be used to measure the results. Over the course of the study, a thorough knowledge of the immune checkpoint dynamics and their influence on the immune response is made possible by the consistent evaluation that is ensured by the use of a standardized common unit of measure.
Measured: [ Time Frame: up to 60 months]
Measurement of Angiogenic Factors (e.g., VEGF)
This study aims to evaluate the angiogenic factor Vascular Endothelial Growth Factor (VEGF) post-treatment. VEGF plays a crucial role in regulating angiogenesis and is linked to tumor vascularization. The serum concentrations of VEGF-A/C will be measured by ELISA, providing valuable insights into the angiogenic processes linked to the treatment outcomes.
Measured: [ Time Frame: up to 60 months]
Measurement of Tumor Proliferation Markers (e.g., Ki67, P16)
The study incorporates the evaluation of tumor proliferation markers, including Ki67 a protein present in active phases of cell cycle and P16 a tumor suppressor protein, utilizing assays of immunohistochemistry (IHC) to measure the expression levels of Ki67 and P16 (in percent %). These assays play a pivotal role in quantifying the extent of tumor cell division, giving valuable insights into the rate of tumor growth. This comprehensive analysis of proliferation markers aims to enhance our understanding of the tumor's behavior upon the therapeutic approach.
Measured: [ Time Frame: up to 60 months].
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 Feb 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lebanese University
- Sponsor type
- University, hospital or other
- Collaborators
- Haykel Hospital
- Responsible party
- Principal investigator, Nehman Makdissy, Lebanese University
- Investigators
- Nehman Makdissy, Professor, Study chair, Lebanese University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307249
- Sponsor's protocol ID
- LU_HH_Cancer_Precision Therapy
- Acronym
- PTST_PALBEVA
- Status last verified
- Mar 2024
- First submitted
- 5 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Therapy for Solid Tumors: Synergistic Inhibition of Cell Proliferation and Angiogenesis Via CDK4/6 and Anti-VEGF Approach Targeting LncRNA Expression
- ClinicalTrials.gov ID
- NCT06307249
- Acronym / sponsor ID
- PTST_PALBEVA / LU_HH_Cancer_Precision Therapy
- Conditions
- Cancer, Solid Tumor, Colorectal Cancer, Breast Cancer, Ovarian Cancer, Lung Cancer
- Keywords
- LncRNA, Anti-VEGF, CDK4/6 inhibitor, Gene Polymorphism, Palbociclib, Bevacizumab, Inflammation, Immune Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lebanese UniversityUniversity, hospital or other
- Collaborators
- Haykel Hospital
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This innovative clinical trial applies a comprehensive strategy to study the complex interplay of biomarkers, immune responses, angiogenesis, and proliferation in solid tumor progression. This approach integrates the selective cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, such as Palbociclib, with the angiogenesis inhibitor, like Bevacizumab. This dual-targeted therapy holds promise for treating various solid tumors, including colorectal cancer, breast cancer, lung cancer, ovarian cancer, and others.
A focal point of the study is the investigation of Long Non-Coding RNA (LncRNA) , chosen for its potential as a prognostic and predictive biomarker. LncRNA plays a multifaceted role in cellular processes, influencing cell cycle checkpoints, angiogenesis, and metastasis. Its aberrant expression across different cancers positions as a key subject of investigation, particularly considering its potential association with polymorphisms. Beyond its involvement in proliferation and angiogenesis. It also adds an additional layer of complexity, crucial for understanding patient outcomes.
The investigation initiates with colorectal cancer and extends to other solid cancers, including lung, ovarian, and breast cancers. Patients are stratified into carriers or non-carriers of the risk allele, forming the foundation for precision-driven treatments. The study design comprises two distinct groups within the colorectal cancer cohort, Group 1 and Group 2, involving patients with and without the risk allele. These groups undergo combined therapy with a CDK4/6 inhibitor and anti-VEGF. Similarly, the distribution is maintained for patients with and without the risk allele in other solid tumors (lung, breast, ovarian, etc.), receiving the same combined therapy tailored to their molecular profiles whether taken as 1st line of treatment or 2nd line of treatment.
Precise pre-treatment assessments establish baseline parameters, while post-treatment evaluations cover outcomes such as tumor progression, cancer regression, survival rates, and thromboembolic events. The interdependent relationship between proliferative tumor cells and angiogenesis, coupled with the potential impact of thromboembolism, is pivotal for cancer progression. Dysregulated cell cycle machinery, often involving overactive cyclin-dependent kinases (CDKs) like CDK4/6, drives uncontrolled proliferation, leading to a hypoxic microenvironment that triggers angiogenesis. Recognizing this symbiosis, the rationale for combining Palbociclib, a CDK4/6 inhibitor, with Bevacizumab, an anti-VEGF agent, becomes evident. While Palbociclib disrupts the cell cycle progression of proliferating tumor cells, hindering their uncontrolled growth, Bevacizumab concurrently targets the angiogenic process by inhibiting VEGF.
This dual-targeted approach aims to comprehensively address both the proliferative, angiogenic, and thromboembolic facets of tumor biology, potentially leading to a more effective and synergistic anti-tumor response.
Four groups will be considered:
Carrier Groups:
Group 1: "Carrier First-line Combined Therapy Group", C-FL-CT; Group 2: "Carrier Second-line Combined Therapy Group", C-SL-CT
Non-carrier Groups:
Group 3: "Non-carrier First-line Combined Therapy Group", NC-FL-CT; Group 4: "Non-carrier Second-line Combined Therapy Group", NC-SL-CT "Carrier"" denotes the patient who possesses the risk allele of the LncRNA CDKN2B-AS1.
Group 1: This group of patients, who are carriers of the risk alleles, will receive combined therapy as the initial first-line treatment without prior chemotherapy.
Group 2: This group of patients, who are carriers of the risk alleles, will receive combined therapy after having undergone prior chemotherapy, making it the second-line treatment.
Group 3: This group of patients, who are non-carriers of the risk alleles, will receive combined therapy as the initial first-line treatment without prior chemotherapy.
Group 4: This group of patients, who are non-carriers of the risk alleles, will receive combined therapy after having undergone prior chemotherapy, making it the second-line treatment.
In summary, the study integrates precision medicine, biomarker-driven therapies, and a comprehensive understanding of the molecular basis of tumor progression, including thromboembolism. This approach offers a promising avenue for the development of personalized and effective treatments for various solid tumors, emphasizing not only efficacy and safety but also the overall effectiveness of the proposed therapeutic interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Carrier First-line Combined Therapy Group C-FL-CT | Experimental | Genetic: SNP, Drug: Palbociclib 125mg, Drug: BevacizumabThis group of patients, who are carriers of the risk alleles, will receive combined therapy as the initial first-line treatment without prior chemotherapy. |
| Carrier Second-line Combined Therapy Group C-SL-CT | Experimental | Genetic: SNP, Drug: Palbociclib 125mg, Drug: BevacizumabThis group of patients, who are carriers of the risk alleles, will receive combined therapy after having undergone prior chemotherapy, making it the second-line treatment. |
| Non-carrier First-line Combined Therapy Group NC-FL-CT | Experimental | Genetic: SNP, Drug: Palbociclib 125mg, Drug: BevacizumabThis group of patients, who are non-carriers of the risk alleles, will receive combined therapy as the initial first-line treatment without prior chemotherapy. |
| Non-carrier Second-line Combined Therapy Group NC-SL-CT | Experimental | Genetic: SNP, Drug: Palbociclib 125mg, Drug: BevacizumabThis group of patients, who are non-carriers of the risk alleles, will receive combined therapy after having undergone prior chemotherapy, making it the second-line treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNPAlso: Risk Allele(s)Diagnostics of patients' carriers or not of the risk allele(s) | Genetic | Carrier First-line Combined Therapy Group C-FL-CT, Carrier Second-line Combined Therapy Group C-SL-CT, Non-carrier First-line Combined Therapy Group NC-FL-CT, Non-carrier Second-line Combined Therapy Group NC-SL-CT |
| Palbociclib 125mgAlso: anti-CDK4/6Palbociclib 125mg/day/os over 21 days every 28 days | Drug | Carrier First-line Combined Therapy Group C-FL-CT, Carrier Second-line Combined Therapy Group C-SL-CT, Non-carrier First-line Combined Therapy Group NC-FL-CT, Non-carrier Second-line Combined Therapy Group NC-SL-CT |
| BevacizumabAlso: Anti-VEGF10mg/kg every 21 days | Drug | Carrier First-line Combined Therapy Group C-FL-CT, Carrier Second-line Combined Therapy Group C-SL-CT, Non-carrier First-line Combined Therapy Group NC-FL-CT, Non-carrier Second-line Combined Therapy Group NC-SL-CT |
Primary outcome
Assessment of Cancer Progression
Time frame: [Time Frame: up to 60 months]
The assessment of cancer progression will be conducted using the standardized TNM staging system and applying the Response Evaluation Criteria (RECIST) guideline (ver. 1.1). Progression-Free Survival (PFS), a key primary clinical endpoint for assessing cancer progression, will be calculated as the duration (in months) from the date of enrollment in the study until the tumor progresses, new lesions appear, or until the participant's death from any cause based on RECIST guidelines, considering an increase in tumor size or the appearance of new lesions according to imaging assessments (e.g., CT, MRI, or PET scans) and clinical evaluations (including tumor markers and histopathological analysis).
Identification of Potential Biomarkers
Time frame: [ Time Frame: Once at the moment of the patient's enrollment in the study]
Finding and characterizing new biomarkers linked to thromboembolism and the advancement of cancer is the aim of this result. The evaluation will pay particular attention to Long Non-Coding RNAs (LncRNAs). At the time of study enrollment, biological samples (such as blood or tissue) from enrolled patients will be collected as part of the identification procedure. With Ct (Cycle threshold) serving as the standard unit of measurement for all genes, the evaluation will employ quantitative PCR (qPCR) to study and assess the expression and polymorphisms of the investigated genes. This thorough evaluation seeks to further our knowledge of the molecular markers and the course of cancer, shedding light on new pathways for diagnosis and treatment that might lead to better patient outcomes
Evaluation of Treatment Response to Palbociclib and Bevacizumab Combination Therapy
Time frame: [ Time Frame: up to 60 months]
This main outcome evaluates the extent to which patients responding to combination therapy are managing both angiogenesis and the cancer cell cycle progression. The percentage change in tumor size, a measure of therapy efficacy, will be calculated using the RECIST criteria in the evaluation.
5 secondary outcomes
Survival Rates
Time frame: [ Time Frame: up to 60 months]
Adverse Events
Time frame: [ Time Frame: up to 60 months]
Assessment of Immune Checkpoint Expression (e.g., PD-1 and CTLA-4)
Time frame: [ Time Frame: up to 60 months]
Measurement of Angiogenic Factors (e.g., VEGF)
Time frame: [ Time Frame: up to 60 months]
Measurement of Tumor Proliferation Markers (e.g., Ki67, P16)
Time frame: [ Time Frame: up to 60 months].
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nehman Makdissy, Professor study chair
Lebanese University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNP, Palbociclib 125mg and Bevacizumab in people with Cancer and Solid Tumor, run by Lebanese University at 2 sites in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nehman Makdissy, Professor (71210250 ext. +961, nehman.makdissy@ul.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Cancer Progression (time frame: [Time Frame: up to 60 months]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.