Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Melanoma - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00185302

Purpose

The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic melanoma who have received at least one and no more than two chemotherapies.

Condition	Intervention	Phase
Non-Resectable Metastatic Melanoma	Drug: SH T03632B Drug: SH T03632C	Phase II

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of MS-275, a Histone Deacetylase Inhibitor, Comparing 2 Dosage Schedules in Patients With Metastatic Melanoma

Further study details as provided by Bayer:

Primary Outcome Measures:

Tumor response rate (complete or partial response according to RECIST)

Secondary Outcome Measures:

Time to tumor progression
Survival at 6 months

Study Start Date:	December 2004
Estimated Study Completion Date:	November 2006

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:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Metastatic melanoma
At least one and no more than two chemotherapies
Use of highly effective birth control methods in females of child-bearing potential
Able to swallow and retain intact investigational drug tablets,

Exclusion Criteria:

Active malignancy in the last five years
Previous participation in another trial within the last 4 weeks
Pregnancy, breast feeding
HIV infection
Brain metastasis
Concomitant use of corticosteroids or valproic acid
Uncontrolled intercurrent illness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185302

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Schering Pharma AG, Germany, Medical Affairs

+49 30 468 11800

More Information

Study ID Numbers:	309100, EudraCT No. 2004-002395-41
Study First Received:	September 12, 2005
Last Updated:	May 2, 2007
ClinicalTrials.gov Identifier:	NCT00185302
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 14, 2009