NCT00783393

SCH 52365 Phase II Clinical Study: A Study on the Efficacy and Safety of Monotherapy With SCH 52365 in Patients With First Relapsed Anaplastic Astrocytoma (Study P03745)

Completed Phase 2 Last updated 15 May 2017

What this trial tests

Phase 2 trial testing Temozolomide in Astrocytoma in 32 participants. Completed in 17 June 2005.

Timeline

27 May 2003

Primary endpoint
17 June 2005

17 June 2005

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	27 May 2003
Primary completion	17 June 2005
Estimated completion	17 June 2005

Drugs / interventions tested

• Temozolomide (temozolomide) — full drug profile →

Conditions studied

• Astrocytoma — all drugs for Astrocytoma →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Astrocytoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of the study is to evaluate the efficacy (overall response) and safety of temozolomide in Step 1 at the dose and regimen approved in the US and the EU countries (28 day cycles of temozolomide at 150 to 200 mg/m2 once daily for 5 consecutive days with a 23 day rest period) in patients with anaplastic astrocytoma at first relapse.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.