Overview

Dose Escalation Study of SH U04722 in Solid Tumors

Status:
Terminated

Trial end date:
2007-10-01

Target enrollment:
0

Participant gender:
All

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 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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Bayer

Criteria

Inclusion Criteria:-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 Criteria:- 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)