Dose Escalation Study of SH U04722 in Solid Tumors - Full Text View

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.

Condition	Intervention	Phase
Tumors	Drug: SH U04722	Phase I

MedlinePlus related topics:

Cancer

Drug Information available for:

Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

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

Further study details as provided by Bayer:

Primary Outcome Measures:

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 Outcome Measures:

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

Enrollment:	11
Study Start Date:	January 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375453

Locations


Japan

	Iruma-gun, Japan

	Koto-Ku, Japan

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Schering Pharma AG, Germany, Medical Affairs	Japan (NSKK): phone: 1-888-BERLEX4

More Information

Study ID Numbers:	91526, 310681
First Received:	September 12, 2006
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00375453
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:

Paclitaxel

Advanced Solid Tumors

Study placed in the following topic categories:

Paclitaxel

ClinicalTrials.gov processed this record on November 06, 2008

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00375453