GlioblastomaNCT00723827
Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)
An observational study of Glioblastoma and Glioma, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the following points that are in question and doubt: Incidence of adverse events under actual conditions of use (Serious and Nonserious… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioblastoma, Glioma, Astrocytoma
- What is being tested?
- Temozolomide and Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 682 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Sep 2011
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with newly diagnosed glioblastoma multiforme. Participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Who may be able to join
- Participants who are prescribed with temozolomide by local labeling:
- participants with newly diagnosed glioblastoma multiforme;
- participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Who cannot join
- N/A
About this study
Official title: Temodal (Temozolomide) Post Marketing Surveillance Protocol
The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the following points that are in question and doubt:
- Incidence of adverse events under actual conditions of use (Serious and Nonserious Adverse Events);
- Adverse Drug Reactions not shown in the directions for use (will be stated as Unexpected Adverse Reaction);
- Adverse Event caused by misuse, abuse, or drug interactions;
- Other information concerned with safety or efficacy.
- Conditions
- Glioblastoma, Glioma, Astrocytoma
- Being tested
- Temozolomide, Radiotherapy
- Medical subject headings
- Glioblastoma, Glioma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodal, Temodar, SCH 052365, MK-7365
Administration of temozolomide based on the product labeling.
RadiotherapyRadiation
Also called Radiation therapy, irradiation
Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide \& radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide). Receives: Drug: Temozolomide; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events (AEs)
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of vaccine, whether or not considered related to the medicinal product.
Measured: Complete study duration & 30 days after completion (up to approximately 7.5 months)
Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs)
An unexpected ADR was defined as an adverse reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information.
Measured: Complete study duration & 30 days after completion (up to approximately 7.5 months)
Number of Temozolomide Misuse or Abuse Events
Drug abuse was defined as the use of the study drug for a non-therapeutic effect.
Misuse was defined as use of the study medication in a way that was not prescribed.
Measured: Complete study duration & 30 days after completion (up to approximately 7.5 months)
Number of Temozolomide Drug Interactions
Drug interaction was defined as a chemical or physiological reaction that can occur when two different drugs are taken together.
Measured: Complete study duration & 30 days after completion (up to approximately 7.5 months)
Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD)
The response ratings were based on the judgment of the investigator.
Measured: Complete study duration (up to approximately 6.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2011
- Study completionSep 2011
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 GlioblastomaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723827
- Sponsor's protocol ID
- P05557
- Status last verified
- Jan 2015
- First submitted
- 25 Jul 2008
- Last updated
- 30 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temodal (Temozolomide) Post Marketing Surveillance Protocol
- ClinicalTrials.gov ID
- NCT00723827
- Acronym / sponsor ID
- P05557
- Conditions
- Glioblastoma, Glioma, Astrocytoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Posted 8 Jan 2013
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 surveillance is to evaluate the postmarketing safety and efficacy of Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the following points that are in question and doubt:
- Incidence of adverse events under actual conditions of use (Serious and Nonserious Adverse Events);
- Adverse Drug Reactions not shown in the directions for use (will be stated as Unexpected Adverse Reaction);
- Adverse Event caused by misuse, abuse, or drug interactions;
- Other information concerned with safety or efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Drug: Temozolomide, Radiation: RadiotherapyParticipants with newly diagnosed glioblastoma multiforme (treat with temozolomide \& radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with newly diagnosed glioblastoma multiforme. Participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Key inclusion criteria (3 listed)
- Participants who are prescribed with temozolomide by local labeling:
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| TemozolomideAlso: Temodal, Temodar, SCH 052365, MK-7365Administration of temozolomide based on the product labeling. | Drug | All Participants |
| RadiotherapyAlso: Radiation therapy, irradiationRadiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme. | Radiation | All Participants |
Primary outcome
Number of Participants Experiencing Adverse Events (AEs)
Time frame: Complete study duration & 30 days after completion (up to approximately 7.5 months)
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of vaccine, whether or not considered related to the medicinal product.
Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs)
Time frame: Complete study duration & 30 days after completion (up to approximately 7.5 months)
An unexpected ADR was defined as an adverse reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information.
Number of Temozolomide Misuse or Abuse Events
Time frame: Complete study duration & 30 days after completion (up to approximately 7.5 months)
Drug abuse was defined as the use of the study drug for a non-therapeutic effect. Misuse was defined as use of the study medication in a way that was not prescribed.
Number of Temozolomide Drug Interactions
Time frame: Complete study duration & 30 days after completion (up to approximately 7.5 months)
Drug interaction was defined as a chemical or physiological reaction that can occur when two different drugs are taken together.
Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD)
Time frame: Complete study duration (up to approximately 6.5 months)
The response ratings were based on the judgment of the investigator.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma and Glioma, run by Merck Sharp & Dohme LLC.
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 3 inclusion and 1 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 30 Jan 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2013). 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?
Number of Participants Experiencing Adverse Events (AEs) (time frame: Complete study duration & 30 days after completion (up to approximately 7.5 months)). The study lists 5 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 30 Jan 2015.