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

NCT00723827 | Completed Results

• 1 other identifier: P05557
• Study Type: observational
• Target: 682
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioblastoma; Glioma; Astrocytoma

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

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; Radiation: Radiotherapy

Interventions

Temozolomide DRUG

Administration of temozolomide based on the product labeling.

Also known as: Temodal, Temodar, SCH 052365, MK-7365

All Participants

Radiotherapy RADIATION

Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.

Also known as: Radiation therapy, irradiation

All Participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Glioblastoma; Glioma; Astrocytoma

Interventions

Temozolomide; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Physical Phenomena

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 30, 2015
• Results First Posted: January 8, 2013

Record last verified: 2015-01