Glioblastoma MultiformePhase 1NCT01308684
A Dose- and Efficacy-Finding Study of RO5323441 in Combination With Avastin (Bevacizumab) in Patients With Recurrent Glioblastoma
A Phase 1 study testing RO5323441 + bevacizumab [Avastin] and bevacizumab [Avastin] in people with Glioblastoma Multiforme, run by Hoffmann-La Roche at 4 sites in 4 countries.
Trial summary
This open-label, multicenter study will evaluate the safety and efficacy of RO5323441 in combination with Avastin (bevacizumab) in patients with recurrent glioblastoma. In the dose-finding part, patients will receive intravenous escalating doses of RO5323441 in combination with 10 mg/kg Avastin once every two weeks. 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?
- RO5323441 + bevacizumab [Avastin] and bevacizumab [Avastin]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesin 4 countries
- Study dates
- May 2011to Feb 2013
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, >/=18 years of age
- Histologically confirmed glioblastoma
- Radiographic demonstration of disease progression by Response Assessment in Neurooncology (RANO) criteria following prior therapy
- Availability of at least 1 formalin-fixed paraffin-embedded tumor tissue sample
- If receiving corticosteroids, patients must have been on a stable or decreasing dose of corticosteroids
- Prior standard radiotherapy for glioblastoma
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- Karnofsky Performance status >/=70
- Over 4 weeks since prior surgical resection
- Over 12 weeks from radiotherapy
- Over 4 weeks from anticancer agents
Who cannot join
- Patients had second or later glioblastoma relapse
- Patients received more than one systemic treatment regimen for glioblastoma
- Patients have secondary glioblastoma
- Prior treatment with Avastin
- Patients unable to undergo Magnetic Resonance Imaging (MRI)
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Open-label, Combined Dose-finding (Phase I) and Efficacy-finding (Phase II) Study of RO5323441 in Combination With Bevacizumab for Patients With Recurrent Glioblastoma
This open-label, multicenter study will evaluate the safety and efficacy of RO5323441 in combination with Avastin (bevacizumab) in patients with recurrent glioblastoma. In the dose-finding part, patients will receive intravenous escalating doses of RO5323441 in combination with 10 mg/kg Avastin once every two weeks. In the efficacy-finding part, patients will be randomized to receive the established dose (from the dose-finding part) of RO5323441 plus Avastin or Avastin alone. Patients in the dose-finding part may continue treatment with RO5323441 and Avastin on the study until evidence of progressive disease or unacceptable adverse events happen. In the efficacy-finding part, patients will receive study treatment until disease progression or death.
- Conditions
- Glioblastoma Multiforme
- Being tested
- RO5323441 + bevacizumab [Avastin], bevacizumab [Avastin]
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO5323441 + bevacizumab [Avastin]Drug
Dose-Finding part: RO5323441 intravenous escalating doses once every two weeks; Efficacy-Finding part: established dose from the Dose-Finding part; Avastin: 10 mg/kg intravenously once every two weeks
bevacizumab [Avastin]Drug
Efficacy-Finding part: 10 mg/kg intravenously once every two weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RO5323441 + bevacizumab [Avastin] |
| 2 | Experimental | Not described Receives: Drug: bevacizumab [Avastin] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Finding Part: Dose limiting toxicity
Measured: Day 28
Efficacy-Finding part: Progression-free survival
Measured: From baseline to disease progression or death (>12 months)
Secondary outcomes (12)
Dose-Finding part: Pharmacokinetics of RO5323441 and Avastin when combined
Measured: From baseline to disease progression or death (>12 months)
Dose-Finding part: Safety (incidence of adverse events)
Measured: From baseline to disease progression or death (>12 months)
Dose-Finding part: Efficacy (tumor response according to Response Assessment in Neurooncology (RANO) criteria
Measured: From baseline to disease progression or death (>12 months)
Dose-Finding part: Glioblastoma biomarker
Measured: From baseline to disease progression or death (>12 months)
Efficacy-Finding part: Overall Response Rate
Measured: From baseline to disease progression or death (>12 months)
Efficacy-Finding part: Disease Control Rate
Measured: From baseline to disease progression or death (>12 months)
Efficacy-Finding part: Duration of Response
Measured: From baseline to disease progression or death (>12 months)
Efficacy-Finding part: Progression-free survival
Measured: From baseline to disease progression or death (>12 months)
Efficacy-Finding part: Overall Survival
Measured: From baseline to disease progression or death (>12 months)
Efficacy-Finding part: Safety (incidence of adverse events)
Measured: From baseline to disease progression or death (>12 months)
Efficacy-Finding part: Glioblastoma biomarker
Measured: From baseline to disease progression or death (>12 months)
Efficacy-Finding part: Pharmacokinetics (serum levels) of RO5323441 and Avastin when combined
Measured: From baseline to disease progression or death (>12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2013
- Study completionFeb 2013
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT01308684
- Sponsor's protocol ID
- BP25389
- Other IDs
- 2010-021795-29
- Status last verified
- Nov 2016
- First submitted
- 2 Mar 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Combined Dose-finding (Phase I) and Efficacy-finding (Phase II) Study of RO5323441 in Combination With Bevacizumab for Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT01308684
- Acronym / sponsor ID
- BP25389
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 4 Mar 2011 (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.
This open-label, multicenter study will evaluate the safety and efficacy of RO5323441 in combination with Avastin (bevacizumab) in patients with recurrent glioblastoma. In the dose-finding part, patients will receive intravenous escalating doses of RO5323441 in combination with 10 mg/kg Avastin once every two weeks. In the efficacy-finding part, patients will be randomized to receive the established dose (from the dose-finding part) of RO5323441 plus Avastin or Avastin alone. Patients in the dose-finding part may continue treatment with RO5323441 and Avastin on the study until evidence of progressive disease or unacceptable adverse events happen. In the efficacy-finding part, patients will receive study treatment until disease progression or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RO5323441 + bevacizumab [Avastin] |
| 2 | Experimental | Drug: bevacizumab [Avastin] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult patients, >/=18 years of age
- Histologically confirmed glioblastoma
- Radiographic demonstration of disease progression by Response Assessment in Neurooncology (RANO) criteria following prior therapy
- Availability of at least 1 formalin-fixed paraffin-embedded tumor tissue sample
- If receiving corticosteroids, patients must have been on a stable or decreasing dose of corticosteroids
Key exclusion criteria (5 listed)
- Patients had second or later glioblastoma relapse
- Patients received more than one systemic treatment regimen for glioblastoma
- Patients have secondary glioblastoma
- Prior treatment with Avastin
- Patients unable to undergo Magnetic Resonance Imaging (MRI)
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 |
|---|---|---|
| RO5323441 + bevacizumab [Avastin]Dose-Finding part: RO5323441 intravenous escalating doses once every two weeks; Efficacy-Finding part: established dose from the Dose-Finding part; Avastin: 10 mg/kg intravenously once every two weeks | Drug | 1 |
| bevacizumab [Avastin]Efficacy-Finding part: 10 mg/kg intravenously once every two weeks | Drug | 2 |
Primary outcome
Dose-Finding Part: Dose limiting toxicity
Time frame: Day 28
Efficacy-Finding part: Progression-free survival
Time frame: From baseline to disease progression or death (>12 months)
12 secondary outcomes
Dose-Finding part: Pharmacokinetics of RO5323441 and Avastin when combined
Time frame: From baseline to disease progression or death (>12 months)
Dose-Finding part: Safety (incidence of adverse events)
Time frame: From baseline to disease progression or death (>12 months)
Dose-Finding part: Efficacy (tumor response according to Response Assessment in Neurooncology (RANO) criteria
Time frame: From baseline to disease progression or death (>12 months)
Dose-Finding part: Glioblastoma biomarker
Time frame: From baseline to disease progression or death (>12 months)
Efficacy-Finding part: Overall Response Rate
Time frame: From baseline to disease progression or death (>12 months)
Efficacy-Finding part: Disease Control Rate
Time frame: From baseline to disease progression or death (>12 months)
Efficacy-Finding part: Duration of Response
Time frame: From baseline to disease progression or death (>12 months)
Efficacy-Finding part: Progression-free survival
Time frame: From baseline to disease progression or death (>12 months)
Efficacy-Finding part: Overall Survival
Time frame: From baseline to disease progression or death (>12 months)
Efficacy-Finding part: Safety (incidence of adverse events)
Time frame: From baseline to disease progression or death (>12 months)
Efficacy-Finding part: Glioblastoma biomarker
Time frame: From baseline to disease progression or death (>12 months)
Efficacy-Finding part: Pharmacokinetics (serum levels) of RO5323441 and Avastin when combined
Time frame: From baseline to disease progression or death (>12 months)
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 2 Nov 2016.
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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
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO5323441 + bevacizumab [Avastin] and bevacizumab [Avastin] in people with Glioblastoma Multiforme, run by Hoffmann-La Roche at 4 sites in 4 countries.
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 10 inclusion and 5 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, France, Switzerland, United Kingdom. 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?
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?
Dose-Finding Part: Dose limiting toxicity (time frame: Day 28). The study lists 2 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 2 Nov 2016.