Trial Condition(s):

Tumors

Dose Escalation Study of SH U04722 in Solid Tumors

Bayer Identifier:

91526

ClinicalTrials.gov Identifier:

NCT00375453

EudraCT Number:

Not Available

Terminated/Withdrawn

Trial Purpose

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.

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)

Trial Summary

Enrollment Goal
10
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Tocosol-Paclitaxel (BAY86-5312)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Gan Ken Ariake Byoin

Koutou-ku, Japan, 135-8850

Status
Completed
 
Locations

Saitama Ikadaigaku Byoin

Iruma-gun, Japan, 350-0495

Status
Completed
 
Locations

Saitamaikadaigaku Kokusai Iryo Senta

Hidaka-shi, Japan, 350-1298

Status
Completed
 

Trial Design