Status:
TERMINATED
Dose Escalation Study of SH U04722 in Solid Tumors
Lead Sponsor:
Bayer
Conditions:
Tumors
Eligibility:
All Genders
20-74 years
Phase:
PHASE1
Brief Summary
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 U04...
Detailed Description
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.
Eligibility Criteria
Inclusion
- Refractory to conventional antineoplastic treatment or no standard therapy option available-ECOG Performance Status score of \< 2-Agreement not to take vitamin E products such as Juvela (except for over-the-counter \[OTC\] and diet supplements).
Exclusion
- Patients treated with other unapproved drugs/investigational drugs, chemotherapy, biological response modifiers, immunotherapy or endocrinotherapy within 4 weeks prior to entry in this study or nitrosoureas within 6 weeks before initial dosing of SH U04722 -Patients on concurrent therapy with warfarin or coumarin derivatives.-Patients who had radiation therapy within 2 weeks prior to entry into this study. -Patients with a history of serious hypersensitivity to taxanes.-Patients with current peripheral neuropathy (? Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 2)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00375453
Start Date
January 1 2007
End Date
October 1 2007
Last Update
December 31 2014
Active Locations (3)
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1
Hidaka-shi, Saitama, Japan, 350-1298
2
Iruma-gun, Saitama, Japan, 350-0495
3
Koutou-ku, Tokyo, Japan, 135-8850