Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00723827

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 points 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

MedlinePlus related topics: Cancer Radiation Therapy

Drug Information available for: Temozolomide

U.S. FDA Resources

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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Occurrence of adverse events. [ Time Frame: Cohort 1 is observed from start of treatment with temozolomide and concomitant radiotherapy until the end of 6 cycles of subsequent temozolomide monotherapy. Cohort 2 is observed from the start of temozolomide treatment until the end of it. ] [ Designated as safety issue: Yes ]
Efficacy, defined by best tumor response evaluation based on commonly used guidelines for brain tumors like MacDonald criteria, progression free survival, and overall survival until completion of observation. [ Time Frame: Cohort 1 is observed from start of treatment with temozolomide and concomitant radiotherapy until the end of 6 cycles of subsequent temozolomide monotherapy. Cohort 2 is observed from the start of temozolomide treatment until the end of it. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	900
Study Start Date:	March 2008
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients with newly diagnosed glioblastoma multiforme.	Drug: Temozolomide Administration of temozolomide based on the product labeling. Radiation: Radiotherapy Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.
2 Patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	Drug: Temozolomide Administration of temozolomide based on the product labeling.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients with newly diagnosed glioblastoma multiforme. Patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Criteria

Inclusion Criteria:

Patients who are prescribed with temozolomide by local labeling:
- patients with newly diagnosed glioblastoma multiforme;
- patients 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

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Korea, Republic of
Coordinating Location	Recruiting
Seoul, Korea, Republic of

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05557
Study First Received:	July 25, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00723827 History of Changes
Health Authority:	South Korea: Institutional Review Board; South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:

Neuroectodermal Tumors
Glioblastoma
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Antineoplastic Agents, Alkylating
Glioma
Alkylating Agents
Temozolomide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Astrocytoma
Antineoplastic Agents
Neoplasms, Nerve Tissue
Temozolomide
Pharmacologic Actions
Neuroectodermal Tumors

Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Glioma
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009