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

Glioblastoma Clinical Trial

Official title:

Temodal (Temozolomide) Post Marketing Surveillance Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723827
• Other study ID #: P05557
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: January 19, 2015
• Start date: March 2008
• Est. completion date: September 2011

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review BoardSouth Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 682
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Astrocytoma
• Glioblastoma
• Glioma

Intervention

Drug:
• Temozolomide
Administration of temozolomide based on the product labeling.

Radiation:
• Radiotherapy
Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Complete study duration & 30 days after completion (up to approximately 7.5 months)	Yes
Primary	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.	Complete study duration & 30 days after completion (up to approximately 7.5 months)	Yes
Primary	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.	Complete study duration & 30 days after completion (up to approximately 7.5 months)	Yes
Primary	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.	Complete study duration & 30 days after completion (up to approximately 7.5 months)	Yes
Primary	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.	Complete study duration (up to approximately 6.5 months)	No