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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00723827
First received: July 25, 2008
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Glioblastoma
Glioma
Astrocytoma
 Drug: Temozolomide
Radiation: Radiotherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Temodal (Temozolomide) Post Marketing Surveillance Protocol

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Complete study duration & 30 days after completion (up to approximately 7.5 months) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]

    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    The response ratings were based on the judgment of the investigator.


Enrollment: 682
Study Start Date: March 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723827

Locations
Korea, Republic of
Coordinating Location
Seoul, Korea, Republic of
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00723827     History of Changes
Other Study ID Numbers: P05557
Study First Received: July 25, 2008
Results First Received: December 5, 2012
Last Updated: December 5, 2012
Health Authority: South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Astrocytoma
Glioblastoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013