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Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)

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ClinicalTrials.gov Identifier: NCT00723827
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : January 8, 2013
Last Update Posted : January 30, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment
Glioblastoma Glioma Astrocytoma Drug: Temozolomide Radiation: Radiotherapy

Study Design
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Study Type : Observational
Actual Enrollment : 682 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Temodal (Temozolomide) Post Marketing Surveillance Protocol
Study Start Date : March 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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).
 Drug: Temozolomide
Administration of temozolomide based on the product labeling.
Other Names:
  • Temodal
  • Temodar
  • SCH 052365
  • MK-7365

Radiation: Radiotherapy
Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.
Other Names:
  • Radiation therapy
  • irradiation


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.

  5. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • N/A
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00723827    
Other Study ID Numbers: P05557
First Posted: July 29, 2008    Key Record Dates
Results First Posted: January 8, 2013
Last Update Posted: January 30, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents