Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Objective Response of Complete Response or Partial Response

Outcome Description:

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR persisted on repeat imaging study at least (≥) 4 weeks after initial documentation of response. PR, for bidimensionally measurable disease, was a decrease by ≥50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response recorded any time while the participant was receiving treatment. External Response Review Committee (ERRC) assessment.

Outcome Time Frame:

Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

A5961166

NCT ID:

NCT00404495

Start Date:

April 2007

Completion Date:

December 2011

Related Keywords:

• Glioma
• Medulloblastoma
• Glioma
• Medulloblastoma