NCT00375453

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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

9 months

First QC Date

September 12, 2006

Last Update Submit

December 30, 2014

Conditions

Tumors

Keywords

PaclitaxelAdvanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • 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 Arms (1)

Arm 1

EXPERIMENTAL
Drug: SH U04722

Interventions

SH U04722DRUG
Arm 1

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Hidaka-shi, Saitama, 350-1298, Japan

Location

Unknown Facility

Iruma-gun, Saitama, 350-0495, Japan

Location

Unknown Facility

Koutou-ku, Tokyo, 135-8850, Japan

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2006

First Posted

September 13, 2006

Study Start

January 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

December 31, 2014

Record last verified: 2014-12

Locations

JP(3)