Glioblastoma MultiformePhase 2NCT00267592
Safety and Efficacy of Talampanel in Glioblastoma Multiforme
A Phase 2 study testing Talampanel, Radiation Therapy (RT) 5 days a week + and temozolomide(TMZ) 75mg in people with Glioblastoma Multiforme, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
The purpose of this study is to estimate overall survival for adult patients with newly diagnosed glioblastoma multiforme treated with talampanel during radiation therapy with concurrent and adjuvant temozolomide. This study will also determine the toxicity and toxicity rate of talampanel for this therapeutic regimen. 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?
- Talampanel, Radiation Therapy (RT) 5 days a week + and temozolomide(TMZ) 75mg
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Feb 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 18 years of age
- Patients must have histologically confirmed supratentorial Grade IV astrocytoma (glioblastoma multiforme)
- Patients must not have prior radiation therapy, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy. Glucocorticoid therapy is allowed.
- Patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen (on increase for 5 days) prior to the start of treatment.
- Patients must have a Karnofsky performance of at least 60% or more.
Who cannot join
- Patients with serious concurrent infection or medical illness.
- Patients receiving concurrent chemotherapeutics or investigational agents.
About this study
Official title: A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
The purpose of this study is to estimate overall survival for adult patients with newly diagnosed glioblastoma multiforme treated with talampanel during radiation therapy with concurrent and adjuvant temozolomide. This study will also determine the toxicity and toxicity rate of talampanel for this therapeutic regimen.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Talampanel, Radiation Therapy (RT) 5 days a week +, temozolomide(TMZ) 75mg, adjuvant TMZ 200mg
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalampanelDrug
Talampanel administered orally TID beginning the first day and continued until there is talampanel-related toxicity or tumor progression.
Radiation Therapy (RT) 5 days a week +Radiation
temozolomide(TMZ) 75mgDrug
temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks
adjuvant TMZ 200mgDrug
adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| enzyme-inducing antiseizure drug | Experimental | A single-arm study with all subjects assigned to one treatment (radiation + temozolomide + talampanel) but subjects receiving concomitant anti-seizure drugs which could increase study drug elimination had a slightly modified dose/schedule of study drug. The primary endpoint is analyzed as a single group. Receives: Drug: Talampanel; Radiation: Radiation Therapy (RT) 5 days a week +; Drug: temozolomide(TMZ) 75mg; Drug: adjuvant TMZ 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 24 months
Secondary outcomes (1)
Talampanel-related toxicity
Measured: 29 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionSep 2008
- Study completionFeb 2011
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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267592
- Sponsor's protocol ID
- IXR-207-21-189 / NABTT 0304
- Status last verified
- Apr 2016
- First submitted
- 19 Dec 2005
- Last updated
- 19 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00267592
- Acronym / sponsor ID
- IXR-207-21-189 / NABTT 0304
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 21 Dec 2005 (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 estimate overall survival for adult patients with newly diagnosed glioblastoma multiforme treated with talampanel during radiation therapy with concurrent and adjuvant temozolomide. This study will also determine the toxicity and toxicity rate of talampanel for this therapeutic regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| enzyme-inducing antiseizure drug | Experimental | Drug: Talampanel, Radiation: Radiation Therapy (RT) 5 days a week +, Drug: temozolomide(TMZ) 75mg, Drug: adjuvant TMZ 200mgA single-arm study with all subjects assigned to one treatment (radiation + temozolomide + talampanel) but subjects receiving concomitant anti-seizure drugs which could increase study drug elimination had a slightly modified dose/schedule of study drug. The primary endpoint is analyzed as a single group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must be 18 years of age
- Patients must have histologically confirmed supratentorial Grade IV astrocytoma (glioblastoma multiforme)
- Patients must not have prior radiation therapy, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy. Glucocorticoid therapy is allowed.
- Patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen (on increase for 5 days) prior to the start of treatment.
- Patients must have a Karnofsky performance of at least 60% or more.
Key exclusion criteria (2 listed)
- Patients with serious concurrent infection or medical illness.
- Patients receiving concurrent chemotherapeutics or investigational agents.
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 |
|---|---|---|
| TalampanelTalampanel administered orally TID beginning the first day and continued until there is talampanel-related toxicity or tumor progression. | Drug | enzyme-inducing antiseizure drug |
| Radiation Therapy (RT) 5 days a week + | Radiation | enzyme-inducing antiseizure drug |
| temozolomide(TMZ) 75mgtemozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks | Drug | enzyme-inducing antiseizure drug |
| adjuvant TMZ 200mgadjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months. | Drug | enzyme-inducing antiseizure drug |
Primary outcome
Overall Survival
Time frame: 24 months
1 secondary outcome
Talampanel-related toxicity
Time frame: 29 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 19 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Talampanel, Radiation Therapy (RT) 5 days a week + and temozolomide(TMZ) 75mg in people with Glioblastoma Multiforme, run by Teva Branded Pharmaceutical Products R&D, Inc..
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 5 inclusion and 2 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 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall Survival (time frame: 24 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 19 May 2016.