Glioblastoma MultiformePhase 2ARTNCT02029573
Efficacy and Safety of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma
A Phase 2 study testing Atorvastatin, Temozolomide and Radiotherapy in people with Glioblastoma Multiforme, run by King Fahad Medical City at 1 site in Saudi Arabia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Atorvastatin, Temozolomide and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2014to 31 Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Atorvastatin, Temozolomide, Radiotherapy
- Keywords
- Phase II, Atorvastatin, Temozolomide, Radiotherapy, Glioblastoma Multiforme (GBM)
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
80 mg po daily until disease progression or unacceptable toxicity. (starting dose of 40 mg po daily for the first 21 days)
TemozolomideDrug
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
RadiotherapyRadiation
60 Gy in 30 fractions
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin in Combination With Radiotherapy and Temozolomide | Experimental | Not described Receives: Drug: Atorvastatin; Drug: Temozolomide; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival at 6 months (PFS-6)
All efficacy determinations will be based on the Response Assessment in Neuro-Oncology (RANO) response criteria (Wen 2010)
Measured: up to 6 months
Secondary outcomes (3)
Progression free survival
Progression free survival defined as the time the patient enters the study until first progression or death whichever occurs first
Measured: Up to 2-3 years
Overall Survival (OS)
Overall Survival defined as the time the patient enters the study to the date of death due to any cause.
Measured: Up to 2-3 years
Adverse events
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.
Measured: Up to 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study start1 Jan 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Fahad Medical City
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abdullah Khalaf Altwairgi, King Fahad Medical City
- Investigators
- Abdullah K. Altwairgi, MD, Study chair, King Fahad Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029573
- Sponsor's protocol ID
- KFMC-CNS-01
- Acronym
- ART
- Status last verified
- Aug 2017
- First submitted
- 3 Jan 2014
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma
- ClinicalTrials.gov ID
- NCT02029573
- Acronym / sponsor ID
- ART / KFMC-CNS-01
- Conditions
- Glioblastoma Multiforme
- Keywords
- Phase II, Atorvastatin, Temozolomide, Radiotherapy, Glioblastoma Multiforme (GBM)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- King Fahad Medical CityOther government
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 8 Jan 2014 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin in Combination With Radiotherapy and Temozolomide | Experimental | Drug: Atorvastatin, Drug: Temozolomide, Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Atorvastatin80 mg po daily until disease progression or unacceptable toxicity. (starting dose of 40 mg po daily for the first 21 days) | Drug | Atorvastatin in Combination With Radiotherapy and Temozolomide |
| Temozolomide75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy | Drug | Atorvastatin in Combination With Radiotherapy and Temozolomide |
| Radiotherapy60 Gy in 30 fractions | Radiation | Atorvastatin in Combination With Radiotherapy and Temozolomide |
Primary outcome
Progression free survival at 6 months (PFS-6)
Time frame: up to 6 months
All efficacy determinations will be based on the Response Assessment in Neuro-Oncology (RANO) response criteria (Wen 2010)
3 secondary outcomes
Progression free survival
Time frame: Up to 2-3 years
Overall Survival (OS)
Time frame: Up to 2-3 years
Adverse events
Time frame: Up to 2-3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
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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. This study is not recruiting at the moment.
Abdullah K. Altwairgi, MD study chair
King Fahad Medical City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin, Temozolomide and Radiotherapy in people with Glioblastoma Multiforme, run by King Fahad Medical City at 1 site in Saudi Arabia.
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 11 inclusion and 6 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: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival at 6 months (PFS-6) (time frame: up to 6 months). 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 18 Aug 2017.