Glioblastoma MultiformePhase 2NCT01115491
A Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme
A Phase 2 study testing bevacizumab [Avastin] and temozolomide in people with Glioblastoma Multiforme, run by Hoffmann-La Roche at 8 sites in Spain.
Trial summary
This is a Phase II, national, multicenter, open-label, non-comparative study to investigate the efficacy and safety of bevacizumab and temozolomide in patients with recurrent glioblastoma multiforme (GBM) after a first treatment failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- bevacizumab [Avastin] and temozolomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 8 sitesSpain
- Study dates
- Jun 2010to Jul 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age >= 18 years
- Histological diagnosis of glioblastoma multiforme (GBM) documented by surgical resection or biopsy.
- They should be patients in a first relapse treated with radiotherapy and chemotherapy and chemotherapy based on temozolomide 150-200 mg/m2 on days 1 to 5 every 28 days (Stupp regimen) for at least three cycles. At least 4 weeks must have lapsed since previous chemotherapy and 3 months since the last dose of radiotherapy.
- Use of an effective contraceptive method by patients and their partners.
- Stable or decreasing corticosteroid dose for the five days prior to study entry
- Adequate hematological function
- Adequate liver function
- Adequate kidney function
Who cannot join
- Signs of recent bleeding at the MRI of the brain. However, patients with clinically asymptomatic presence of hemosiderin, resolving bleeding changes related to surgery, and presence of punctate hemorrhage in the tumor will be allowed to participate in the study.
- Prior treatment with bevacizumab
- Poorly controlled arterial hypertension
- History of hypertensive crises or hypertensive encephalopathy
- New York Health Association (NYHA) Class II or higher congestive heart failure
- History of myocardial infarction or unstable angina pectoris within six months of study entry
Show all 17Show fewer
- History of stroke or TIA within six months of study entry
- Significant vascular disease within six months of study entry
- History of hemoptysis > grade 2 according to the NCI CTC criteria within one month of study entry
- Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgery, open biopsy, intracranial biopsy, ventriculoperitoneal shunt, or major traumatic lesion within 28 days of study entry.
- Core needle biopsy (excluding intracranial biopsy) or other minor surgery within seven days of randomization. Placement of a central vascular access device (CVAD) if performed in the two days prior to bevacizumab administration
- History of abdominal fistula or gastrointestinal perforation within six months of study entry
- History of intracranial abscess within six months of randomization
- Any prior malignant neoplasm treated with curative intent in the five years prior to study entry, except for adequately controlled limited basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
- Patients with any other metabolic or psychological disease
- Hypersensitivity to products derived from Chinese hamster ovary cells or to other humanized or recombinant human antibodies
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Study site
Barcelona, Barcelona, 08025
Study site
Barcelona, Barcelona, 08907
Study site
Barcelona, Barcelona, 08916
Study site
Madrid, Madrid, 28040
Study site
Madrid, Madrid, 28041
Study site
Madrid, Madrid, 28046
Study site
Valencia, Valencia, 41014
Study site
Valencia, Valencia, 46026
About this study
Official title: A Single Arm Phase II Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme
This is a Phase II, national, multicenter, open-label, non-comparative study to investigate the efficacy and safety of bevacizumab and temozolomide in patients with recurrent glioblastoma multiforme (GBM) after a first treatment failure. Patients will receive bevacizumab 10 mg/kg intravenously every two weeks until disease progression, consent withdrawal, or unacceptable toxicity. Anticipated time on study treatment is 12-24 months.
- Conditions
- Glioblastoma Multiforme
- Being tested
- bevacizumab [Avastin], temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumab [Avastin]Drug
Bevacizumab 10 mg/kg body weight will be administered intravenously every two weeks
temozolomideDrug
Daily by the oral route (dose, 150 mg/m2) on days 1 to 7 and 15 to 21 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: bevacizumab [Avastin]; Drug: temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) - Percentage of Participants With an Event
PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment.
Measured: Baseline (BL), every 28 days, until progression, death or end-of-study, an average of 32 weeks
PFS - Time to Event
PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment. PFS was estimated using the Kaplan-Meier method.
Measured: BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks
PFS: Probability of Remaining Progression Free at 24 Weeks After Beginning the Study
Measured: BL, 24 weeks (after 6th cycle)
Secondary outcomes (3)
Overall Survival - Percentage of Participants With an Event
Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact.
Measured: BL, every 28 days, until death or end-of-study, an average of 32 weeks
Overall Survival - Time to Event
Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact. Median overall survival was estimated using the Kaplan-Meier method.
Measured: BL, every 28 days, until death or end-of-study, an average of 32 weeks
Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)
Overall response was defined as the percentage of participants who obtained CR or PR using adapted MacDonald criteria. CR: disappearance of all index and non-index lesions, confirmed no less than 4 weeks after assessment, no evidence of disease progression; corticosteroid dosage at or below 20 mg hydrocortisone daily; no neurological changes or an improvement as compared to last disease assessment. PR was defined as: Fifty percent or greater decrease in the sum of products of the larger diameter and the larger perpendicular diameter of all index lesions confirmed no less than 4 weeks after assessment, no evidence of disease progression and the absence of progressive, or non-evaluable disease status for non-index legions; unchanged, or decreased corticosteroid dose as compared to the last disease assessment; no neurological changes or an improvement as compared to the neurological examination at last disease assessment.
Measured: BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115491
- Sponsor's protocol ID
- ML25152
- Other IDs
- 2010-019051-21
- Status last verified
- Dec 2014
- First submitted
- 30 Apr 2010
- Last updated
- 8 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase II Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT01115491
- Acronym / sponsor ID
- ML25152
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Posted 8 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II, national, multicenter, open-label, non-comparative study to investigate the efficacy and safety of bevacizumab and temozolomide in patients with recurrent glioblastoma multiforme (GBM) after a first treatment failure. Patients will receive bevacizumab 10 mg/kg intravenously every two weeks until disease progression, consent withdrawal, or unacceptable toxicity. Anticipated time on study treatment is 12-24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: bevacizumab [Avastin], Drug: temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >= 18 years
- Histological diagnosis of glioblastoma multiforme (GBM) documented by surgical resection or biopsy.
- They should be patients in a first relapse treated with radiotherapy and chemotherapy and chemotherapy based on temozolomide 150-200 mg/m2 on days 1 to 5 every 28 days (Stupp regimen) for at least three cycles. At least 4 weeks must have lapsed since previous chemotherapy and 3 months since the last dose of radiotherapy.
- Use of an effective contraceptive method by patients and their partners.
- Stable or decreasing corticosteroid dose for the five days prior to study entry
Key exclusion criteria (17 listed)
- Signs of recent bleeding at the MRI of the brain. However, patients with clinically asymptomatic presence of hemosiderin, resolving bleeding changes related to surgery, and presence of punctate hemorrhage in the tumor will be allowed to participate in the study.
- Prior treatment with bevacizumab
- Poorly controlled arterial hypertension
- History of hypertensive crises or hypertensive encephalopathy
- New York Health Association (NYHA) Class II or higher congestive heart failure
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 |
|---|---|---|
| bevacizumab [Avastin]Bevacizumab 10 mg/kg body weight will be administered intravenously every two weeks | Drug | A |
| temozolomideDaily by the oral route (dose, 150 mg/m2) on days 1 to 7 and 15 to 21 of each cycle | Drug | A |
Primary outcome
Progression-Free Survival (PFS) - Percentage of Participants With an Event
Time frame: Baseline (BL), every 28 days, until progression, death or end-of-study, an average of 32 weeks
PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment.
PFS - Time to Event
Time frame: BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks
PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment. PFS was estimated using the Kaplan-Meier method.
PFS: Probability of Remaining Progression Free at 24 Weeks After Beginning the Study
Time frame: BL, 24 weeks (after 6th cycle)
3 secondary outcomes
Overall Survival - Percentage of Participants With an Event
Time frame: BL, every 28 days, until death or end-of-study, an average of 32 weeks
Overall Survival - Time to Event
Time frame: BL, every 28 days, until death or end-of-study, an average of 32 weeks
Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)
Time frame: BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trials study director
Hoffmann-La Roche
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab [Avastin] and temozolomide in people with Glioblastoma Multiforme, run by Hoffmann-La Roche at 8 sites in Spain.
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 8 inclusion and 17 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 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. 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?
Yes. Results are posted in the registry (first posted 8 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (PFS) - Percentage of Participants With an Event (time frame: Baseline (BL), every 28 days, until progression, death or end-of-study, an average of 32 weeks). 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 8 Dec 2014.