- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02029573
Efficacy and Safety of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma (ART)
August 15, 2017 updated by: Abdullah Khalaf Altwairgi, King Fahad Medical City
Phase II Study of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma
The purpose of this study is to explore the efficacy and safety of Atorvastatin in combination with multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM).The anticipated time on study treatment is until disease progression, and the target sample size is 32 individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Riyadh, Saudi Arabia, 11525
- King Fahad Medical City
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically proven newly diagnosed Malignant Glioblastoma Multiforme or variants (gliosarcoma, glioblastoma with oligodendroglial features, giant cell glioblastoma).
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
- Patients must have an estimated life expectancy of at least 12 weeks.
- No prior chemotherapy or radiotherapy.
- Stable dose of steroid for ≥ 14 days prior to registration.
- Patients must have adequate bone marrow function (e.g., hemoglobin ≥10 g/dl, absolute granulocyte count ≥ 1.5 x 109/L, and platelet count ≥100 x 109/L.
- Adequate liver function (SGPT, SGOT, and alkaline phosphatase ≤ 2.5 times upper limits of normals (ULN) and total bilirubin ≤1.5 x ULN), and adequate renal function (BUN or creatinine ≤1.5 X ULN) prior to starting therapy.
- Paraffin embedded tumour sample available for study.
- Patient consent must be obtained according to local Institutional requirements. The patient must sign the consent form prior to registration.
- Protocol treatment is to begin within 10 working days of patient registration.
Exclusion Criteria:
- Pregnant or lactating women; men and women of childbearing potential must agree to practice an effective method of birth control. Women of childbearing potential must have a negative pregnancy test performed within 14 days prior to registration.
- Concurrent treatment with other experimental drugs or anticancer therapy.
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for > 5 years.
- Prior radiotherapy or systemic cytotoxic chemotherapy .
- Severe, active co-morbidity, defined as follows: Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration, Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or oxygen, Hepatic insufficiency or Active liver disease resulting in clinical jaundice and/or coagulation defects, Acquired immune deficiency syndrome (AIDS) , Significant neurologic or psychiatric disorder which would impair the ability to obtain informed consent, Active uncontrolled or serious infection, active peptic ulcer disease, Any medical condition which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction), Myocardial infarction within 6 months prior to registration, Congestive heart failure, unstable angina, active cardiomyopathy, cardiac arrhythmia, Skeletal muscle disease and other related reticule-endothelial diseases.
- Patients with known hypersensitivity to the study drugs or their components.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Atorvastatin in Combination With Radiotherapy and Temozolomide
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80 mg po daily until disease progression or unacceptable toxicity.
(starting dose of 40 mg po daily for the first 21 days)
75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy
60 Gy in 30 fractions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival at 6 months (PFS-6)
Time Frame: up to 6 months
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All efficacy determinations will be based on the Response Assessment in Neuro-Oncology (RANO) response criteria (Wen 2010)
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up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: Up to 2-3 years
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Progression free survival defined as the time the patient enters the study until first progression or death whichever occurs first
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Up to 2-3 years
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Overall Survival (OS)
Time Frame: Up to 2-3 years
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Overall Survival defined as the time the patient enters the study to the date of death due to any cause.
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Up to 2-3 years
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Adverse events
Time Frame: Up to 2-3 years
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The assessment of safety will be based on the frequency of Adverse Events graded (grade 3+) according to the Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.0 scoring system.
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Up to 2-3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Abdullah K. Altwairgi, MD, King Fahad Medical City
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2014
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
January 3, 2014
First Submitted That Met QC Criteria
January 6, 2014
First Posted (Estimate)
January 8, 2014
Study Record Updates
Last Update Posted (Actual)
August 18, 2017
Last Update Submitted That Met QC Criteria
August 15, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
- Temozolomide
Other Study ID Numbers
- KFMC-CNS-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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