Dose Escalation Study of SH U04722 in Solid Tumors
This study will evaluate the safety and tolerability of SH U04722 in patients with solid tumor cancers. In addition, this study will identify the recommended dose and administration schedule of SH U04722 for phase II development in Japanese cancer patients, evaluate the pharmacokinetic profile of SH U04722 and gather preliminary data on the effectiveness of SH U04722 in patients with solid tumors.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I, Open-label, Dose Escalation Study for Evaluation of Safety, Tolerability, Pharmacokinetics, and Tumor-suppressive Efficacy of SH U04722 in Patients With Solid Tumors|
- The number of patients with dose limiting toxicity (DLT) observed between Days 1 and 21 after start of treatment (after first 3 weekly administrations of SH U04722 plus 7 days)
- The number of patients with DLT observed by the end of Week 8
- dose intensity (whether or not 75% of the planned dose can be done) for 8 weeks after the first dosing
|Study Start Date:||January 2007|
|Study Completion Date:||October 2007|
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375453
|Hidaka-shi, Saitama, Japan, 350-1298|
|Iruma-gun, Saitama, Japan, 350-0495|
|Koutou-ku, Tokyo, Japan, 135-8850|
|Study Director:||Bayer Study Director||Bayer|